This study is in progress, not accepting new patients

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

a study on Uterine Fibroids

Summary

Eligibility
for females ages 21 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Vanessa Jacoby, MD
Headshot of Vanessa Jacoby
Vanessa Jacoby

Description

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.

Keywords

Uterine Fibroids, Fibroids, Radiofrequency ablation, Myomectomy, Leiomyoma, Myofibroma, Radiofrequency ablation of fibroids, Myomectomy of fibroids, Women undergoing radiofrequency ablation., Women undergoing myomectomy

Eligibility

You can join if…

Open to females ages 21 years and up

  • 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

You CAN'T join if...

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

Locations

  • UCSF
    San Francisco California 94115 United States
  • UC Irvine Medical Center
    Irvine California 92868 United States

Lead Scientist at UCSF

  • Vanessa Jacoby, MD
    Dr. Vanessa Jacoby is a Professor of Obstetrics, Gynecology, and Reproductive Sciences, the Associate Vice Chancellor for Clinical Research, and Director of the Clinical and Translational Science Institute. She is a clinical researcher with a focus on improving care for people with uterine fibroids.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02100904
Study Type
Observational
Participants
About 578 people participating
Last Updated