<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/NCT03028610</url>
  </required_header>
  <id_info>
    <org_study_id>GFA-001</org_study_id>
    <nct_id>NCT03028610</nct_id>
  </id_info>
  <brief_title>Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System</brief_title>
  <official_title>Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Women's Hospital Tübingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Women's Hospital Tübingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate&#xD;
      pregnancies following the Acessa™ treatment of uterine myomas in women who desire future&#xD;
      childbearing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spontaneous abortion</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ectopic pregnancy</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaginal delivery and either</measure>
    <time_frame>three years</time_frame>
    <description>i. Uncomplicated delivery or ii. Delivery with complications such as:&#xD;
Premature rupture of the membranes (PROM) or&#xD;
Preterm premature rupture of the membranes (PPROM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caesarean section delivery and either</measure>
    <time_frame>three years</time_frame>
    <description>i. Uncomplicated delivery or ii. Delivery with complications such as:&#xD;
Preterm delivery&#xD;
Preterm labor&#xD;
Uterine rupture&#xD;
Stillbirths&#xD;
Postpartum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure-related complications within 1 month post-procedure</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-treatment changes in myoma size as determined by ultrasound</measure>
    <time_frame>3, 6, 36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>One or More Uterine Fibroids</condition>
  <arm_group>
    <arm_group_label>Acessa™ System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>radiofrequency generator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>radiofrequency generator</intervention_name>
    <arm_group_label>Acessa™ System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are premenopausal and aged 18 to 40 years.&#xD;
&#xD;
          2. Have already consented to have their fibroids treated with the Acessa™ procedure.&#xD;
&#xD;
          3. Desire pregnancy within two years following Acessa™ treatment&#xD;
&#xD;
          4. Have a normal endometrial cavity as delineated by sonohysterogram within 6 months&#xD;
             prior to treatment.&#xD;
&#xD;
          5. Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory&#xD;
             pelvic exam.&#xD;
&#xD;
          6. Have fibroids identified by transvaginal ultrasound with:&#xD;
&#xD;
               1. ≤6 (six) fibroids of ≤5 cm at the major diameter&#xD;
&#xD;
               2. a total uterine volume of no greater than 300 cc&#xD;
&#xD;
          7. Patients with type 2 fibroids are acceptable for inclusion.&#xD;
&#xD;
          8. Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).&#xD;
&#xD;
          9. Are capable of providing informed consent.&#xD;
&#xD;
         10. Are willing and able to comply with all study tests, procedures, and assessment tools&#xD;
             during screening and up to 3 years post treatment.&#xD;
&#xD;
         11. Are able to pass a pre-operative health exam (ASA I-III).&#xD;
&#xD;
         12. Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or&#xD;
             who are planning such treatments may be enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have contraindications for laparoscopic surgery and/or general anesthesia.&#xD;
&#xD;
          2. Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded&#xD;
             as these are generally accessible to hysteroscopic approaches. Cervical myomas are&#xD;
             difficult to treat and present a greater risk of bladder or urethral injury.&#xD;
&#xD;
          3. Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous&#xD;
             fibroids.&#xD;
&#xD;
          4. Have known or suspected abdominal adhesions which are expected to complicate&#xD;
             laparoscopic surgery.&#xD;
&#xD;
          5. Have known or suspected untreated intra-uterine adhesions or uterine septum.&#xD;
&#xD;
          6. Have previously undergone endometrial ablation, uterine artery embolization, or&#xD;
             uterine artery ligation/occlusion, high-intensity focused ultrasound, laparoscopic,&#xD;
             hysteroscopic or abdominal myomectomy, or any other uterine-preserving technique for&#xD;
             reduction of menstrual bleeding.&#xD;
&#xD;
          7. Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs&#xD;
             (NSAIDs), aspirin, and clopidogrel&#xD;
&#xD;
          8. Are pregnant or lactating.&#xD;
&#xD;
          9. Have known or suspected severe endometriosis.&#xD;
&#xD;
         10. Have known or suspected adenomyosis.&#xD;
&#xD;
         11. Have active or history of pelvic inflammatory disease.&#xD;
&#xD;
         12. Have a history of or evidence of gynecologic malignancy or pre-malignancy within the&#xD;
             past five years.&#xD;
&#xD;
         13. Have had pelvic radiation.&#xD;
&#xD;
         14. Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed&#xD;
             consent.&#xD;
&#xD;
         15. In the medical judgment of the investigator should not participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Y Brucker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Women's Hospital</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</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>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</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/NCT03028610
org study id: GFA-001
nct id: NCT03028610
lead sponsor: 
has dmc: No
Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate
      pregnancies following the Acessa™ treatment of uterine myomas in women who desire future
      childbearing
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Spontaneous abortion
time frame: 6 months
measure: Ectopic pregnancy
time frame: three years
measure: Vaginal delivery and either
time frame: three years
description: i. Uncomplicated delivery or ii. Delivery with complications such as:
Premature rupture of the membranes (PROM) or
Preterm premature rupture of the membranes (PPROM)
measure: Caesarean section delivery and either
time frame: three years
description: i. Uncomplicated delivery or ii. Delivery with complications such as:
Preterm delivery
Preterm labor
Uterine rupture
Stillbirths
Postpartum
measure: Procedure-related complications within 1 month post-procedure
time frame: 1 month
measure: Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie
time frame: 1 month
measure: Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score
time frame: three years
measure: Post-treatment changes in myoma size as determined by ultrasound
time frame: 3, 6, 36 months
arm group label: Acessa™ System
arm group type: Experimental
description: radiofrequency generator
intervention type: Device
intervention name: radiofrequency generator
arm group label: Acessa™ System
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Sara Y Brucker, MD
role: Principal Investigator
affiliation: University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
sharing ipd: No