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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02100904
First received: March 27, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.

The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation 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. Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the laparoscopic RF ablation surgery 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. We will determine long-term efficacy of RFA by evaluating the rate of re-treatment for symptomatic fibroids after the RFA procedure. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF ablation surgery will be asked to consent to complete a brief study questionnaire with information on demographics, work history, professional training, and practice setting.

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 Intervention
Uterine Fibroids
Procedure: Radiofrequency ablation of fibroids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Changes in fibroid-related symptoms after the Acessa procedure. [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
    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 Acessa procedure. [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Operative complications [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women undergoing radiofrequency ablation.
All women in the trial will be in this group who receive treatment with radiofrequency ablation.
Procedure: Radiofrequency ablation of fibroids

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with uterine fibroids who are planning to undergo or have undergone radiofrenquency ablation treatment.

Criteria

Inclusion Criteria:

  • Planning to undergo or have undergone RF ablation for treatment of uterine fibroids.
  • Able to give informed consent

Exclusion Criteria:

  • <21 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100904

Contacts
Contact: Lisa Abinanti 415-353-9978 lisa.abinanti@ucsf.edu
Contact: Stephanie Lemp 650-784-0531 fibroids@uscf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Stephanie Lemp    650-784-0531    fibroids@ucsf.edu   
Contact: Lisa Abinanti    415-353-9978    lisa.abinanti@ucsf.edu   
Principal Investigator: Vanessa Jacoby, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02100904     History of Changes
Other Study ID Numbers: 14-13325
Study First Received: March 27, 2014
Last Updated: May 29, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Fibroids
Radiofrequency ablation

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 28, 2014