Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Uterine Fibroids Clinical Trial

— ULTRA Registry  

Official title:

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02100904
• Other study ID #: 14-13325
• Status: Active, not recruiting
• Start date: May 2014
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 578
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Procedure:
• Radiofrequency ablation of fibroids

• Myomectomy of fibroids

Locations

Country	Name	City	State
United States	Fibroid and Pelvic Wellness Center of Georgia	Alpharetta	Georgia
United States	Tassone Advanced Gynecology	Austin	Texas
United States	Gynecology Institute of Chicago	Chicago	Illinois
United States	UT Southwestern	Dallas	Texas
United States	Dedicated to Women	Dover	Delaware
United States	Duke University	Durham	North Carolina
United States	Women's Healthcare Associates of IL, SC	Homewood	Illinois
United States	UC Irvine Medical Center	Irvine	California
United States	MacArthur Medical Center	Irving	Texas
United States	Acacia OBGYN	San Antonio	Texas
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fibroid-related symptoms after the RFA or myomectomy procedure.	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.	Baseline to 3 years
Secondary	Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.		Baseline to 6 weeks
Secondary	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
Secondary	Pregnancy rate after the RFA or myomectomy procedure.		Baseline to 3 years

External Links

•   Fibroid Trials at UCSF