Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100904
Recruitment Status : Recruiting
First Posted : April 1, 2014
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date March 27, 2014
First Posted Date April 1, 2014
Last Update Posted Date November 5, 2019
Study Start Date May 2014
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2019)
Changes in fibroid-related symptoms after the RFA or myomectomy procedure. [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: March 27, 2014)
Changes in fibroid-related symptoms after the Acessa procedure. [ Time Frame: 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.
Change History Complete list of historical versions of study NCT02100904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 4, 2019)
  • Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. [ Time Frame: Baseline to 6 weeks ]
  • Operative complications [ Time Frame: 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. [ Time Frame: Baseline to 3 years ]
Original Secondary Outcome Measures
 (submitted: March 27, 2014)
  • Rate of re-intervention for recurrent fibroid symptoms following the Acessa procedure. [ Time Frame: Baseline to 6 weeks ]
  • Operative complications [ Time Frame: 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 Acessa procedure. [ Time Frame: Baseline to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Official Title Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Uterine Fibroids
Intervention
  • Procedure: Radiofrequency ablation of fibroids
  • Procedure: Myomectomy of fibroids
Study Groups/Cohorts
  • Women undergoing radiofrequency ablation.
    Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
    Intervention: 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.
    Intervention: Procedure: Myomectomy of fibroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 4, 2019)
800
Original Estimated Enrollment
 (submitted: March 27, 2014)
100
Estimated Study Completion Date January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Vanessa Monzon 510-999-4326 fibroids@ucsf.edu
Contact: Ruth Gebrezghi 510-999-4326 fibroids@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02100904
Other Study ID Numbers 14-13325
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2019