Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System

Study Overview
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Brief Summary
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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

Official Title
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Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System

Conditions
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One or More Uterine Fibroids

Intervention / Treatment
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* Device: radiofrequency generator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acessa™ System<br>radiofrequency generator | Device: radiofrequency generator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortion |  | 6 months | 
| Ectopic pregnancy |  | three years | 
| Vaginal delivery and either | i. Uncomplicated delivery or ii. Delivery with complications such as: Premature rupture of the membranes (PROM) or Preterm premature rupture of the membranes (PPROM) | three years | 
| Caesarean section delivery and either | i. Uncomplicated delivery or ii. Delivery with complications such as: Preterm delivery Preterm labor Uterine rupture Stillbirths Postpartum | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related complications within 1 month post-procedure |  | 1 month | 
| Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie |  | 1 month | 
| Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score |  | three years | 
| Post-treatment changes in myoma size as determined by ultrasound |  | 3, 6, 36 months |