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Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System

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ClinicalTrials.gov Identifier: NCT03028610
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief Summary:
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

Condition or disease Intervention/treatment Phase
One or More Uterine Fibroids Device: radiofrequency generator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
Study Start Date : January 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Acessa™ System
radiofrequency generator
Device: radiofrequency generator



Primary Outcome Measures :
  1. Spontaneous abortion [ Time Frame: 6 months ]
  2. Ectopic pregnancy [ Time Frame: three years ]
  3. Vaginal delivery and either [ Time Frame: three years ]

    i. Uncomplicated delivery or ii. Delivery with complications such as:

    • Premature rupture of the membranes (PROM) or
    • Preterm premature rupture of the membranes (PPROM)

  4. Caesarean section delivery and either [ Time Frame: three years ]

    i. Uncomplicated delivery or ii. Delivery with complications such as:

    • Preterm delivery
    • Preterm labor
    • Uterine rupture
    • Stillbirths
    • Postpartum


Secondary Outcome Measures :
  1. Procedure-related complications within 1 month post-procedure [ Time Frame: 1 month ]
  2. Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie [ Time Frame: 1 month ]
  3. Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score [ Time Frame: three years ]
  4. Post-treatment changes in myoma size as determined by ultrasound [ Time Frame: 3, 6, 36 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are premenopausal and aged 18 to 40 years.
  2. Have already consented to have their fibroids treated with the Acessa™ procedure.
  3. Desire pregnancy within two years following Acessa™ treatment
  4. Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
  5. Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
  6. Have fibroids identified by transvaginal ultrasound with:

    1. ≤6 (six) fibroids of ≤5 cm at the major diameter
    2. a total uterine volume of no greater than 300 cc
  7. Patients with type 2 fibroids are acceptable for inclusion.
  8. Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
  9. Are capable of providing informed consent.
  10. Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
  11. Are able to pass a pre-operative health exam (ASA I-III).
  12. Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or who are planning such treatments may be enrolled in the study.

Exclusion Criteria:

  1. Have contraindications for laparoscopic surgery and/or general anesthesia.
  2. Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded as these are generally accessible to hysteroscopic approaches. Cervical myomas are difficult to treat and present a greater risk of bladder or urethral injury.
  3. Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
  4. Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
  5. Have known or suspected untreated intra-uterine adhesions or uterine septum.
  6. Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation/occlusion, high-intensity focused ultrasound, laparoscopic, hysteroscopic or abdominal myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding.
  7. Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
  8. Are pregnant or lactating.
  9. Have known or suspected severe endometriosis.
  10. Have known or suspected adenomyosis.
  11. Have active or history of pelvic inflammatory disease.
  12. Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
  13. Have had pelvic radiation.
  14. Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
  15. In the medical judgment of the investigator should not participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028610


Contacts
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Contact: Sara Y Brucker, MD 0049707180791 sara.brucker@med.uni-tuebingen.de

Locations
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Germany
University Women's Hospital Recruiting
Tübingen, Germany, 72076
Contact: Bernhard Krämer, MD    0049707182211    bernhard.kraemer@med.uni-tuebingen.de   
Sponsors and Collaborators
University Women's Hospital Tübingen
Investigators
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Principal Investigator: Sara Y Brucker, MD University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany

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Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT03028610     History of Changes
Other Study ID Numbers: GFA-001
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases