NCT02100904

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 578 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation of fibroids
PROCEDURE	Myomectomy of fibroids

Timeline

• Start date: 2014-05-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2014-04-01
• Last updated: 2026-03-11

Locations

12 sites across 1 country: United States