Neoplasms

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Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

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Neoplasms, Connective Tissue

Connective Tissue Diseases

All women in the trial will be in this group who receive treatment using the Acessa device.

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.

Radiofrequency ablation of fibroids

Vanessa Jacoby, MD

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.

Uterine Leiomyoma Treatment With Radiofrequency Ablation

Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.

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.

University of California, Davis

University of California, Irvine

University of California, Los Angeles

University of California, San Diego

University of California, San Francisco

Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).

About 25% of women in the trial will be in the group who receive treatment with myomectomy.

Myomectomy of fibroids

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).

The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.

UC San Francisco will have 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.

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Uterine Leiomyoma Treatment With Radiofrequency Ablation	NCT01840124	Uterine Fibroid...	Radiofrequency ...	21 Years -	University of California, San Francisco
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry	NCT02100904	Uterine Fibroid...	Radiofrequency ... Myomectomy of f...	21 Years -	University of California, San Francisco
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry	NCT02100904	Uterine Fibroid...	Radiofrequency ... Myomectomy of f...	21 Years -	University of California, San Francisco
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry	NCT02100904	Uterine Fibroid...	Radiofrequency ... Myomectomy of f...	21 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for radiofrequency ablation of fibroids