Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.