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Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System (NCT03028610)

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
  • Device: radiofrequency generator
    Ages eligible for Study
    18 Years to 40 Years
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Are premenopausal and aged 18 to 40 years.
    • Have already consented to have their fibroids treated with the Acessa™ procedure.
    • Desire pregnancy within two years following Acessa™ treatment
    • Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
    • Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
    • Have fibroids identified by transvaginal ultrasound with:
    • ≤6 (six) fibroids of ≤5 cm at the major diameter
    • a total uterine volume of no greater than 300 cc
    • Patients with type 2 fibroids are acceptable for inclusion.
    • Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
    • Are capable of providing informed consent.
    • Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
    • Are able to pass a pre-operative health exam (ASA I-III).
    • 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:
    • Have contraindications for laparoscopic surgery and/or general anesthesia.
    • 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.
    • Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
    • Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
    • Have known or suspected untreated intra-uterine adhesions or uterine septum.
    • 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.
    • Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
    • Are pregnant or lactating.
    • Have known or suspected severe endometriosis.
    • Have known or suspected adenomyosis.
    • Have active or history of pelvic inflammatory disease.
    • Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
    • Have had pelvic radiation.
    • Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
    • In the medical judgment of the investigator should not participate in the study.

    1 locations

    Germany (1)
    • University Women's Hospital
      recruiting
      Tübingen, Germany, 72076
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 December, 2015
    Updated:
    10 July, 2017
    Participants:
    25
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