Summary

for females ages 21 years and up (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion
Vanessa Jacoby, MD

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

  • University of California, San Francisco in progress, not accepting new patients
    San Francisco California 94115 United States
  • University of California, Davis not yet accepting patients
    Sacramento California 95817 United States

Lead Scientist

  • Vanessa Jacoby, MD
    Dr. Vanessa Jacoby is an obstetrician gynecologist with a research program focused on surgical gynecology. She has studied long-term health outcomes of hysterectomy and oophorectomy. She is the principal investigator of prospective cohort study of women with BRCA1 or BRCA2 mutations who undergo risk-reducing salpingo-oophorectomy funded by the American Cancer Society.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Fibroid Trials at UCSF
ID
NCT02100904
Study Type
Observational
Last Updated