<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/NCT03769792</url>
  </required_header>
  <id_info>
    <org_study_id>1/1/2018 (Sep 8)</org_study_id>
    <nct_id>NCT03769792</nct_id>
  </id_info>
  <brief_title>Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries</brief_title>
  <official_title>Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OASIS Diagnostics S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OASIS Diagnostics S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the study is to evaluate the effectiveness and safety of the impedance&#xD;
      spectroscopy device prototype in detection of anal sphincter injuries in women in the early&#xD;
      postpartum period. The study is prospective. The study group comprises 24 patients; included&#xD;
      in it 6-8 weeks after natural delivery. The planned participation of each patient in the&#xD;
      study is up to 4 weeks and three visits will take place at that time.&#xD;
&#xD;
      After obtaining written consent, at the screening visit (V0) each patient will undergo a&#xD;
      physical examination, blood samples for laboratory tests and stool samples for calprotectin&#xD;
      concentration assessment will be collected.&#xD;
&#xD;
      On the second visit (V1), after the final verification of inclusion/exclusion criteria,&#xD;
      impedance spectroscopy using tested device will be performed in each patient, the electrical&#xD;
      impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage&#xD;
      will be evaluated. Full gynecological and proctological examination (including a&#xD;
      gynecological speculum, two-handed examination, rectal examination and anoscopy) will be&#xD;
      carried out.&#xD;
&#xD;
      On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and&#xD;
      safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected&#xD;
      data will be used to select the optimal therapeutic method for each participant individually.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">December 23, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anal sphincters injury</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by subsequent measures:&#xD;
Sphincter continuity in physical examination,&#xD;
Sphincter tension in physical examination,&#xD;
OASIS classification of perineal tears in transanal ultrasonography&#xD;
Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference)&#xD;
Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters)&#xD;
anorectal manometry assessment to measure anal sphincters function&#xD;
All measurements are used to estimate the presence, extent and severity of anal sphincter injury.&#xD;
The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from pelvic floor muscles using impedance spectroscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>8 weeks</time_frame>
    <description>Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obstetric Anal Sphincter Injury</condition>
  <condition>Delivery, Obstetric</condition>
  <arm_group>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 women will be included in the study and divided into two subgroups.&#xD;
12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification.&#xD;
Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification.&#xD;
The planned interventions are:&#xD;
Blood and faeces tests&#xD;
Impedance spectroscopy test&#xD;
Full gynecological and proctological examination&#xD;
Transanal ultrasonography&#xD;
Anorectal manometry</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood and faeces tests</intervention_name>
    <description>During V0 - Laboratory tests, particularly for calprotectin concentration assessment</description>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Impedance spectroscopy test</intervention_name>
    <description>During V1 - the electrical impedance of pelvic floor muscles will be measured</description>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Full gynecological and proctological examination</intervention_name>
    <description>During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy</description>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transanal ultrasonography</intervention_name>
    <description>During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.</description>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anorectal manometry</intervention_name>
    <description>During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.</description>
    <arm_group_label>Impedance spectroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  after natural delivery and post-partum period (6-8 weeks after delivery)&#xD;
&#xD;
          -  physiological pregnancy&#xD;
&#xD;
          -  observed a perianal tear of grade 1-4 in the OASIS classification&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of acute diseases during treatment&#xD;
&#xD;
          -  presence of chronic diseases untreated or insufficiently treated (e.g. poorly&#xD;
             controlled hypertension),&#xD;
&#xD;
          -  presence of diseases, with symptoms of fecal incontinence,&#xD;
&#xD;
          -  previous proctological operations,&#xD;
&#xD;
          -  the presence of inflammatory bowel diseases in the stage of exacerbation,&#xD;
&#xD;
          -  treatment in the last year due to severe, progressive, uncontrolled cardiac,&#xD;
             pulmonary, nephrological, infectious or psychiatric disease, which course could affect&#xD;
             the patient's risk due to participation in study,&#xD;
&#xD;
          -  significant deviations from the norm in a physical examination during V0 visit or&#xD;
             laboratory tests taken during the same visit,&#xD;
&#xD;
          -  significant disease symptoms so far undiagnosed and reported during the V0 visit&#xD;
&#xD;
          -  presence or suspected malignant disease or previous oncological treatment during the&#xD;
             last 5 years,&#xD;
&#xD;
          -  presence of a cardiac stimulator or cardioverter-defibrillator,&#xD;
&#xD;
          -  severe surgery or severe trauma in the last year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grzegorz Surkont, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centrum Medyczne Byc Kobieta s.c.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centrum Medyczne Byc Kobieta s.c.</name>
      <address>
        <city>Łódź</city>
        <state>Lodzkie</state>
        <zip>95-070</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>http://www.oasis-diagnostics.eu</url>
    <description>Sponsor's website</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstetrical anal sphincter injury</keyword>
  <keyword>Impedance spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03769792
org study id: 1/1/2018 (Sep 8)
nct id: NCT03769792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of the study is to evaluate the effectiveness and safety of the impedance
      spectroscopy device prototype in detection of anal sphincter injuries in women in the early
      postpartum period. The study is prospective. The study group comprises 24 patients; included
      in it 6-8 weeks after natural delivery. The planned participation of each patient in the
      study is up to 4 weeks and three visits will take place at that time.

      After obtaining written consent, at the screening visit (V0) each patient will undergo a
      physical examination, blood samples for laboratory tests and stool samples for calprotectin
      concentration assessment will be collected.

      On the second visit (V1), after the final verification of inclusion/exclusion criteria,
      impedance spectroscopy using tested device will be performed in each patient, the electrical
      impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage
      will be evaluated. Full gynecological and proctological examination (including a
      gynecological speculum, two-handed examination, rectal examination and anoscopy) will be
      carried out.

      On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and
      safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected
      data will be used to select the optimal therapeutic method for each participant individually.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Anal sphincters injury
time frame: 8 weeks
description: Assessed by subsequent measures:
Sphincter continuity in physical examination,
Sphincter tension in physical examination,
OASIS classification of perineal tears in transanal ultrasonography
Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference)
Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters)
anorectal manometry assessment to measure anal sphincters function
All measurements are used to estimate the presence, extent and severity of anal sphincter injury.
The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from pelvic floor muscles using impedance spectroscopy.
measure: Adverse events
time frame: 8 weeks
description: Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
arm group label: Impedance spectroscopy
arm group type: Experimental
description: 24 women will be included in the study and divided into two subgroups.
12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification.
Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification.
The planned interventions are:
Blood and faeces tests
Impedance spectroscopy test
Full gynecological and proctological examination
Transanal ultrasonography
Anorectal manometry
intervention type: Diagnostic Test
intervention name: Blood and faeces tests
description: During V0 - Laboratory tests, particularly for calprotectin concentration assessment
arm group label: Impedance spectroscopy
intervention type: Device
intervention name: Impedance spectroscopy test
description: During V1 - the electrical impedance of pelvic floor muscles will be measured
arm group label: Impedance spectroscopy
intervention type: Diagnostic Test
intervention name: Full gynecological and proctological examination
description: During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy
arm group label: Impedance spectroscopy
intervention type: Diagnostic Test
intervention name: Transanal ultrasonography
description: During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
arm group label: Impedance spectroscopy
intervention type: Diagnostic Test
intervention name: Anorectal manometry
description: During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
arm group label: Impedance spectroscopy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Grzegorz Surkont, MD, PhD
role: Principal Investigator
affiliation: Centrum Medyczne Byc Kobieta s.c.
facility: 
country: Poland
url: http://www.oasis-diagnostics.eu
description: Sponsor's website
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No