One or More Uterine Fibroids
University Women's Hospital Tübingen
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|
- 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.
- 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.
- University Women's HospitalrecruitingTübingen, Germany, 72076
31 December, 2015
10 July, 2017