Clinical trial NCT02100904: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Official title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Uterine Fibroids
Keywords: Fibroids
Radiofrequency ablation
Myomectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 578
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
timeFrame: Baseline to 3 years
Secondary outcomes:
measure: Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.
timeFrame: Baseline to 6 weeks
measure: Operative complications
timeFrame: Baseline to 6 weeks
measure: Pregnancy rate after the RFA or myomectomy procedure.
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Medical Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Dover
country: United States
facility: Dedicated to Women
state: Delaware
city: Alpharetta
country: United States
facility: Fibroid and Pelvic Wellness Center of Georgia
state: Georgia
city: Chicago
country: United States
facility: Gynecology Institute of Chicago
state: Illinois
city: Homewood
country: United States
facility: Women's Healthcare Associates of IL, SC
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Austin
country: United States
facility: Tassone Advanced Gynecology
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Irving
country: United States
facility: MacArthur Medical Center
state: Texas
city: San Antonio
country: United States
facility: Acacia OBGYN
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Vanessa Jacoby, MD
role: PRINCIPAL_INVESTIGATOR
References: