Uterine Leiomyoma Treatment With Radiofrequency Ablation

Study Overview
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Brief Summary
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The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure. The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure. Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring board will oversee participant safety and protection.

Official Title
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Uterine Leiomyoma Treatment With Radiofrequency Ablation

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Procedure: Radiofrequency ablation of fibroids


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Premenopausal (at least 1 menstrual period in last 3 months) Age >21years Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia Desires surgical management of fibroids Uterus ≤16 weeks in size All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year. Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study Fibroids will be leiomyomas > 2cm) Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) Able to tolerate laparoscopic surgery Able to give informed consent EXCLUSION CRITERIA Planned treatment for infertility Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) Intracavitary (FIGO Type 0) fibroid Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary) Planned concomitant surgical procedure in addition to treatment of uterine fibroids Use of Essure or any other metallic, implantable device within pelvis Pregnancy Pelvic infection with the last 3 months History of pelvic malignancy and/or pelvic radiation Known or high suspicion for dense pelvic adhesions Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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<br>All women in the trial will be in this group who receive treatment using the Acessa device. | Procedure: Radiofrequency ablation of fibroids<br>* The Acessa device delivers radiofrequency energy to uterine fibroids to destroy fibroid tissue. The patient undergoes a standard laparoscopy of the pelvis. A laparoscopic ultrasound is performed to identify the precise size and location of the fibroids. The Acessa radiofrequency probe is then placed into the fibroid and the radiofrequency energy is delivered. The fibroid tissue is destroyed and the fibroid shrinks down in size to decrease fibroid-related symptoms.<br>* Other names: Acessa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fibroid-related symptoms after the Acessa procedure. | Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life. | Baseline to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention for recurrent fibroid symptoms following the Acessa procedure. |  | Baseline to 3 years | 
| Operative complications | Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder. | Baseline to 6 weeks | 
| Pregnancy after the Acessa procedure |  | Baseline to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids, Radiofrequency ablation