<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260115</url>
  </required_header>
  <id_info>
    <org_study_id>ABS-01EU-2013</org_study_id>
    <secondary_id>95.10 - 5660 - 7811</secondary_id>
    <nct_id>NCT02260115</nct_id>
  </id_info>
  <brief_title>A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy</brief_title>
  <acronym>LABS-1</acronym>
  <official_title>A Randomized, Controlled, Subject and Reviewer-Blinded, Multi-Centre Study To Assess The Safety and Manageability Of LABS™ In Women Undergoing Gynaecologic Laparoscopic Surgery Followed By Second Look Laparoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actamax Surgical Materials LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Actamax Surgical Materials LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain data on the safety and manageability of applying LABS™&#xD;
      to the uterus and other areas of surgical trauma in the pelvis and abdomen following&#xD;
      laparoscopic gynaecologic surgery. In addition, performance data following a clinical&#xD;
      indicated second look laparoscopy will be collected for the purpose of determining sample&#xD;
      size predictions for future trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women undergoing laparoscopic uterine myomectomy, adhesiolysis, treatment of endometriosis or&#xD;
      ovarian cystectomy with associated adhesions and/or endometriosis, and planned, clinically&#xD;
      indicated second look laparoscopy within 4-12 weeks will be enrolled into one of two sub&#xD;
      studies in which the major component of the surgery (as determined by the surgeon) was due&#xD;
      to:&#xD;
&#xD;
        1. Myomectomy Or&#xD;
&#xD;
        2. Other Gynaecology Pathology (repeat myomectomy, adhesiolysis, and/or treatment of&#xD;
           endometriosis, ovarian cystectomy with associated adhesions or endometriotic pathology,&#xD;
           removal of adenomyoma without myomectomy.&#xD;
&#xD;
      The myomectomy sub study will include two arms:&#xD;
&#xD;
        1. Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine&#xD;
           adhesions - blunt dissection only&#xD;
&#xD;
        2. Hybrid Myomectomy - myomectomy with (+/-) adhesions and/or (+/-) endometriosis and/or&#xD;
           (+/-) adenomyomectomy Patients in each sub study (1 or 2) and each arm of the myomectomy&#xD;
           study (a or b) will be randomized to receive LABS™ following their laparoscopic surgery&#xD;
           or current standard of care: surgery only control. All patients will be blinded to their&#xD;
           treatment status until study completion.&#xD;
&#xD;
      Sub study and sub-group allocation as well as randomisation will occur once the initial&#xD;
      laparoscopy is completed but before removal of the laparoscope. Myomectomy patients&#xD;
      randomized to receive LABS™ will then have the device sprayed to the entire surface of the&#xD;
      uterus and other areas of surgical trauma. In all treated patients all sites of surgical&#xD;
      trauma should be completely covered with LABS™ allowing a sprayed margin of at least 3 cm&#xD;
      around the operated or traumatised site.&#xD;
&#xD;
      Patients receiving LABS™ will be compared to patients who have had the current standard of&#xD;
      care: surgery alone. In addition to an overall comparison, they will be compared to patients&#xD;
      in the same sub study (1 or 2) and same arm of the myomectomy study (1a or 1b).&#xD;
&#xD;
      The first two patients entered by each operating surgeon will be allocated to LABS™ and&#xD;
      assessed for the application of LABS™. They will not be counted as fully evaluable randomized&#xD;
      patients. These patients will be sequentially assigned and evaluated. With confirmatory&#xD;
      evaluation of and application of LABS™ on the first patient, the surgeon will be advised to&#xD;
      assign the second. With the same confirmatory evaluation on the second patient and both&#xD;
      patients discharged from hospital the surgeon will be permitted to proceed with the study and&#xD;
      randomise patients.&#xD;
&#xD;
      Both the initial laparoscopic procedure and the clinically indicated second look laparoscopy&#xD;
      will be video recorded to allow for a blinded evaluation of LABS™ application and a separate&#xD;
      blinded evaluation of adhesions and other pathology in all patients - treated and controls.&#xD;
      This evaluation will be cross checked with the operating surgeon's own evaluations and&#xD;
      reconciled according to a specified protocol.&#xD;
&#xD;
      Where, during initial surgery, a second look laparoscopy is no longer considered clinically&#xD;
      indicated but the surgeon randomizes the patient, they will be followed for safety&#xD;
      evaluations only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures</measure>
    <time_frame>Between baseline initial surgery and second look laparoscopy (4-12 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon satisfaction with the device and it's application</measure>
    <time_frame>During baseline initial surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients with myomectomy</measure>
    <time_frame>Baseline initial surgery to second look laparoscopy (4-12 weeks)</time_frame>
    <description>Assessment in the change in adhesion score at the posterior uterus in the LABS™ treated patients compared to the surgery only controls.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in adhesion score of patients with other gynecological pathology</measure>
    <time_frame>Baseline initial surgery to second look laparoscopy (4-12 weeks)</time_frame>
    <description>Assessment of the change in adhesion score at sites of surgery in the LABS™ treated patients compared to the surgery only controls.</description>
  </other_outcome>
  <other_outcome>
    <measure>Other adhesion parameters</measure>
    <time_frame>Baseline initial surgery to second look laparoscopy (4-12 weeks)</time_frame>
    <description>The incidence of patients with adhesions; the number of pre-specified sites with adhesions, and the severity and extent of adhesions at these pre-specified anatomical locations.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Tissue Adhesions</condition>
  <arm_group>
    <arm_group_label>LABS™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Laproscopic Surgery Only</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LABS™</intervention_name>
    <description>hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma</description>
    <arm_group_label>LABS™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Control</intervention_name>
    <description>Surgery only</description>
    <arm_group_label>Surgical Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PREOPERATIVE INCLUSION&#xD;
&#xD;
        Preoperatively the patient must:&#xD;
&#xD;
          -  understand and be able to follow the requirements of the protocol including signing&#xD;
             and dating an Ethics Committee approved Informed Consent prior to undergoing any&#xD;
             protocol related procedures&#xD;
&#xD;
          -  be a premenopausal female who is &gt; 18 and &lt; 46 years old&#xD;
&#xD;
          -  be thought to have gynaecologic pathology requiring laparoscopic surgery - including&#xD;
             uterine fibroids (including those with only anterior fibroid or repeat&#xD;
             myomectomy/previous uterine artery embolization for fibroid), adhesions, and/or&#xD;
             endometriosis with or without associated pathology such as ovarian cysts&#xD;
&#xD;
          -  wish to retain her fertility&#xD;
&#xD;
          -  and thus be considered to clinically benefit from a second-look laparoscopic&#xD;
             procedure;&#xD;
&#xD;
          -  have a willingness to undergo a second-look surgical procedure if clinically indicated&#xD;
&#xD;
          -  have a negative pregnancy test within 5 days of surgery&#xD;
&#xD;
          -  agree to avoid pregnancy using adequate forms of contraception through the time of&#xD;
             performance of second-look laparoscopy (oral contraceptive pill, condom, no sexual&#xD;
             intercourse), and if the patient is undergoing myomectomy that she is aware that it is&#xD;
             good advice to avoid pregnancy for a 12 week period to allow healing of the uterine&#xD;
             scar before becoming pregnant&#xD;
&#xD;
          -  be in good health including an ASA (American Society of Anaesthesiologists) score of 2&#xD;
             or less&#xD;
&#xD;
          -  following physical and medical assessment have no clinically significant or relevant&#xD;
             abnormalities.&#xD;
&#xD;
        PREOPERATIVE EXCLUSION&#xD;
&#xD;
        Preoperatively a patient must not:&#xD;
&#xD;
          -  be unable to give their own written informed consent,&#xD;
&#xD;
          -  have completed her family planning with no desire to maintain fertility,&#xD;
&#xD;
          -  be considered to have no potential clinical benefit from a second look laparoscopy,&#xD;
&#xD;
          -  be breastfeeding,&#xD;
&#xD;
          -  be within 6 weeks post-partum&#xD;
&#xD;
          -  have received or is expected to receive another anti-adhesive treatment within 30 days&#xD;
             prior to enrolment or during enrolment up to adhesion evaluation at second look&#xD;
             laparoscopy,&#xD;
&#xD;
          -  be currently enrolled in another clinical study or has been in another study within&#xD;
             the last 30 days,&#xD;
&#xD;
          -  have received or is expected to receive any other investigational product or technique&#xD;
             within 30 days prior to or during enrolment,&#xD;
&#xD;
          -  have had cancer within 5 years of the initial surgery with the exception of basal cell&#xD;
             carcinoma,&#xD;
&#xD;
          -  have known allergy to dextran, PEG, or FD&amp;C Blue #1,&#xD;
&#xD;
          -  be scheduled to undergo concomitant non-gynaecological surgery,&#xD;
&#xD;
          -  be currently pregnant (including ectopic pregnancy),&#xD;
&#xD;
          -  have received GNRH agonist/antagonist, Depo Provera, danocrine, ulipristal acetate or&#xD;
             similar treatment (except oral contraceptives - and including progesterone only) in&#xD;
             the 4 weeks prior to study,&#xD;
&#xD;
          -  on pre-operative imaging have&#xD;
&#xD;
          -  Largest fibroid &lt; 2 cms&#xD;
&#xD;
          -  Or largest fibroid &gt; 10 cms diameter intramural&#xD;
&#xD;
          -  Or more than 5 large fibroids (large = &gt;8 cms diameter)&#xD;
&#xD;
          -  And/or adenomyoma &gt;10cm identified&#xD;
&#xD;
          -  have a history where it is expected that complete adhesiolysis will not be possible,&#xD;
&#xD;
          -  preoperatively have clinically significant abnormal blood results including:&#xD;
&#xD;
          -  SGOT, SGPT and/or bilirubin &gt; 20% above the upper range of normal and/or&#xD;
&#xD;
          -  BUN and creatinine &gt; 30% above the upper range of normal,&#xD;
&#xD;
          -  have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic,&#xD;
             haematological or coagulation disorders,&#xD;
&#xD;
          -  have insulin dependent diabetes mellitus,&#xD;
&#xD;
          -  be receiving concurrent systemic corticosteroids, antineoplastic agents and/or&#xD;
             radiation therapy,&#xD;
&#xD;
          -  have had previous radiation therapy,&#xD;
&#xD;
          -  have active pelvic or abdominal infection, or other active infection with fever &gt;38°C.&#xD;
&#xD;
        INTRAOPERATIVE INCLUSION&#xD;
&#xD;
        During surgery the patient must have:&#xD;
&#xD;
        • treatment of uterine fibroids, endometriosis, and or adhesions, with or without&#xD;
        associated pathology such as ovarian cysts, and meets all intraoperative&#xD;
        inclusion/exclusion criteria prior to randomisation, including that a SLL is clinically&#xD;
        indicated&#xD;
&#xD;
        Additionally for the myomectomy sub study, during surgery it must be confirmed that:&#xD;
&#xD;
          -  the patient underwent a laparoscopic myomectomy with at least (1) posterior uterine&#xD;
             serosal incision of &gt; 3 cm in length&#xD;
&#xD;
          -  that the major portion of the procedure (in the opinion of the surgeon) was related to&#xD;
             myomectomy&#xD;
&#xD;
          -  that the patient meets all intraoperative inclusion/exclusion criteria prior to&#xD;
             randomisation.&#xD;
&#xD;
        and&#xD;
&#xD;
        • at the completion of the procedure, prior to randomisation, the surgeon continues to&#xD;
        believe that the patient will clinically benefit from second- look laparoscopy.&#xD;
&#xD;
        INTRAOPERATIVE EXCLUSION&#xD;
&#xD;
        Intraoperatively a patient must not:&#xD;
&#xD;
          -  have cancer detected at surgery,&#xD;
&#xD;
          -  be pregnant, including ectopic pregnancy,&#xD;
&#xD;
          -  have a non-gynaecological surgical procedure or entry into the bowel, bladder, or&#xD;
             ureter,&#xD;
&#xD;
          -  have a hysterectomy or other gynaecological procedure that would render the patient&#xD;
             unable to conceive&#xD;
&#xD;
          -  receive the administration of a product that will interfere with the application of&#xD;
             LABS™ Adhesion Barrier Material,&#xD;
&#xD;
          -  receive the use of an approved or unapproved product or strategy for the purpose of&#xD;
             preventing adhesion development,&#xD;
&#xD;
          -  receive fibrin glue, surgical sealant, or other haemostatic agent,&#xD;
&#xD;
          -  undergo an open procedure&#xD;
&#xD;
          -  undergo a posterior colpotomy,&#xD;
&#xD;
          -  undergo insufflation with a gas other than CO2,&#xD;
&#xD;
          -  undergo Laprolift or similar device for elevation of the abdominal wall, as an&#xD;
             alternative to CO2 insufflation,&#xD;
&#xD;
          -  undergo abdominal cavity humidification or oxygenation,&#xD;
&#xD;
          -  undergo robotic surgery,&#xD;
&#xD;
          -  receive irrigants containing, glucocorticoids, antihistamines, heparin or antiseptic&#xD;
             additives.&#xD;
&#xD;
          -  have a postoperative drain&#xD;
&#xD;
          -  does not have complete lysis of any adhesions to the posterior uterus&#xD;
&#xD;
          -  has deep infiltrating endometriosis that is not treated during surgery&#xD;
&#xD;
          -  patient had ovarian cysts with no other pathology&#xD;
&#xD;
          -  be considered to have no clinical indication for a SLL&#xD;
&#xD;
        For the myomectomy sub study the patient:&#xD;
&#xD;
          -  does not undergo laparoscopic myomectomy with at least (1) posterior uterine serosal&#xD;
             incision of &gt; 3 cm in length,&#xD;
&#xD;
          -  has only pedunculated fibroids removed from the posterior aspect of the uterus&#xD;
&#xD;
          -  has adenomyoma alone without fibroids&#xD;
&#xD;
          -  has therapeutic hysteroscopy with treatment of congenital malformation, myomectomy or&#xD;
             treatment of Asherman's syndrome&#xD;
&#xD;
          -  excepting diagnostic hysteroscopy or polypectomy with lactated Ringer's solution (LRS)&#xD;
             undertaken prior to laparoscopy and all fluid removed prior to laparoscopic filming.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rudy DeWilde, MD, ScD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor and Head Department of Gynecology, Obstetrics and Gynecology Oncology, Pius-Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sara Y Brucker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Deputy Head of Department of Gynecology and Obstetrics, University of Tubingen Women's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthias Korell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head Department of Obstetrics and Gynecology, Johanna Etienne-Krankenhaus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George A Pistofidis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director Department of Gynaecological Surgery Lefkos, Stavros Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geoffery H Trew, M.B.B.S</last_name>
    <role>Study Director</role>
    <affiliation>Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johanna Etienne Krankenhaus</name>
      <address>
        <city>Neuss</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pius-Hosptial, European Medical School Oldenburg-Groningen, Carl von Ossietzky University</name>
      <address>
        <city>Oldenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tubingen Women's Hosptial</name>
      <address>
        <city>Tubingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lefkos Stavros Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Greece</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260115
org study id: ABS-01EU-2013
secondary id: 95.10 - 5660 - 7811
nct id: NCT02260115
lead sponsor: 
has dmc: Yes
The purpose of this study is to obtain data on the safety and manageability of applying LABS™
      to the uterus and other areas of surgical trauma in the pelvis and abdomen following
      laparoscopic gynaecologic surgery. In addition, performance data following a clinical
      indicated second look laparoscopy will be collected for the purpose of determining sample
      size predictions for future trials.
Women undergoing laparoscopic uterine myomectomy, adhesiolysis, treatment of endometriosis or
      ovarian cystectomy with associated adhesions and/or endometriosis, and planned, clinically
      indicated second look laparoscopy within 4-12 weeks will be enrolled into one of two sub
      studies in which the major component of the surgery (as determined by the surgeon) was due
      to:

        1. Myomectomy Or

        2. Other Gynaecology Pathology (repeat myomectomy, adhesiolysis, and/or treatment of
           endometriosis, ovarian cystectomy with associated adhesions or endometriotic pathology,
           removal of adenomyoma without myomectomy.

      The myomectomy sub study will include two arms:

        1. Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine
           adhesions - blunt dissection only

        2. Hybrid Myomectomy - myomectomy with (+/-) adhesions and/or (+/-) endometriosis and/or
           (+/-) adenomyomectomy Patients in each sub study (1 or 2) and each arm of the myomectomy
           study (a or b) will be randomized to receive LABS™ following their laparoscopic surgery
           or current standard of care: surgery only control. All patients will be blinded to their
           treatment status until study completion.

      Sub study and sub-group allocation as well as randomisation will occur once the initial
      laparoscopy is completed but before removal of the laparoscope. Myomectomy patients
      randomized to receive LABS™ will then have the device sprayed to the entire surface of the
      uterus and other areas of surgical trauma. In all treated patients all sites of surgical
      trauma should be completely covered with LABS™ allowing a sprayed margin of at least 3 cm
      around the operated or traumatised site.

      Patients receiving LABS™ will be compared to patients who have had the current standard of
      care: surgery alone. In addition to an overall comparison, they will be compared to patients
      in the same sub study (1 or 2) and same arm of the myomectomy study (1a or 1b).

      The first two patients entered by each operating surgeon will be allocated to LABS™ and
      assessed for the application of LABS™. They will not be counted as fully evaluable randomized
      patients. These patients will be sequentially assigned and evaluated. With confirmatory
      evaluation of and application of LABS™ on the first patient, the surgeon will be advised to
      assign the second. With the same confirmatory evaluation on the second patient and both
      patients discharged from hospital the surgeon will be permitted to proceed with the study and
      randomise patients.

      Both the initial laparoscopic procedure and the clinically indicated second look laparoscopy
      will be video recorded to allow for a blinded evaluation of LABS™ application and a separate
      blinded evaluation of adhesions and other pathology in all patients - treated and controls.
      This evaluation will be cross checked with the operating surgeon's own evaluations and
      reconciled according to a specified protocol.

      Where, during initial surgery, a second look laparoscopy is no longer considered clinically
      indicated but the surgeon randomizes the patient, they will be followed for safety
      evaluations only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures
time frame: Between baseline initial surgery and second look laparoscopy (4-12 weeks)
measure: Surgeon satisfaction with the device and it's application
time frame: During baseline initial surgery
measure: Patients with myomectomy
time frame: Baseline initial surgery to second look laparoscopy (4-12 weeks)
description: Assessment in the change in adhesion score at the posterior uterus in the LABS™ treated patients compared to the surgery only controls.
measure: Change in adhesion score of patients with other gynecological pathology
time frame: Baseline initial surgery to second look laparoscopy (4-12 weeks)
description: Assessment of the change in adhesion score at sites of surgery in the LABS™ treated patients compared to the surgery only controls.
measure: Other adhesion parameters
time frame: Baseline initial surgery to second look laparoscopy (4-12 weeks)
description: The incidence of patients with adhesions; the number of pre-specified sites with adhesions, and the severity and extent of adhesions at these pre-specified anatomical locations.
arm group label: LABS™
arm group type: Experimental
description: hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma
arm group label: Surgical Control
arm group type: Sham Comparator
description: Laproscopic Surgery Only
intervention type: Device
intervention name: LABS™
description: hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma
arm group label: LABS™
intervention type: Procedure
intervention name: Surgical Control
description: Surgery only
arm group label: Surgical Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rudy DeWilde, MD, ScD, PhD
role: Principal Investigator
affiliation: Professor and Head Department of Gynecology, Obstetrics and Gynecology Oncology, Pius-Hospital
last name: Sara Y Brucker, MD, PhD
role: Principal Investigator
affiliation: Deputy Head of Department of Gynecology and Obstetrics, University of Tubingen Women's Hospital
last name: Matthias Korell, MD
role: Principal Investigator
affiliation: Head Department of Obstetrics and Gynecology, Johanna Etienne-Krankenhaus
last name: George A Pistofidis, MD
role: Principal Investigator
affiliation: Director Department of Gynaecological Surgery Lefkos, Stavros Hospital
last name: Geoffery H Trew, M.B.B.S
role: Study Director
affiliation: Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Greece
responsible party type: Sponsor
mesh term: Tissue Adhesions