Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Uterine Fibroids

Treatments: Procedure: Myomectomy of fibroids; Procedure: Radiofrequency ablation of fibroids

Study type: Observational

Funder types: Other

Identifiers

NCT02100904

14-13325

Details and patient eligibility

About

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.

Enrollment: 578 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.

• Able to give informed consent

• Speak English or Spanish

  • Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment

Exclusion criteria

• <21 years of age
• Plan to undergo hysteroscopic myomectomy

Trial design

578 participants in 2 patient groups

Women undergoing radiofrequency ablation.

Description:

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

Treatment:

Procedure: Radiofrequency ablation of fibroids

Women undergoing myomectomy

Description:

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

Treatment:

Procedure: Myomectomy of fibroids