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

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02100904

Collaborator

(none)

578

Enrollment

Locations

135

Duration (Months)

48.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Procedure: Radiofrequency ablation of fibroids Procedure: Myomectomy of fibroids

Study Design

Study Type:

Observational

Actual Enrollment :

578 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Women undergoing radiofrequency ablation. Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).	Procedure: Radiofrequency ablation of fibroids
Women undergoing myomectomy About 25% of women in the trial will be in the group who receive treatment with myomectomy.	Procedure: Myomectomy of fibroids

Arm

Intervention/Treatment

Women undergoing radiofrequency ablation.

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

Procedure: Radiofrequency ablation of fibroids

Women undergoing myomectomy

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

Procedure: Myomectomy of fibroids

Outcome Measures

Primary Outcome Measures

Changes in fibroid-related symptoms after the RFA or myomectomy procedure. [Baseline to 3 years]
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.

Secondary Outcome Measures

Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. [Baseline to 6 weeks]
Operative complications [Baseline to 6 weeks]
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.
Pregnancy rate after the RFA or myomectomy procedure. [Baseline to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine Medical Center	Irvine	California	United States	92868
2	University of California, San Diego	San Diego	California	United States	92037
3	University of California, San Francisco	San Francisco	California	United States	94115
4	Dedicated to Women	Dover	Delaware	United States	19904
5	Fibroid and Pelvic Wellness Center of Georgia	Alpharetta	Georgia	United States	30005
6	Gynecology Institute of Chicago	Chicago	Illinois	United States	60605
7	Women's Healthcare Associates of IL, SC	Homewood	Illinois	United States	60430
8	Duke University	Durham	North Carolina	United States	27704
9	Tassone Advanced Gynecology	Austin	Texas	United States	78723
10	UT Southwestern	Dallas	Texas	United States	75390
11	MacArthur Medical Center	Irving	Texas	United States	75062
12	Acacia OBGYN	San Antonio	Texas	United States	78217