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

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ClinicalTrials.gov Identifier: NCT02100904
Recruitment Status : Recruiting
First Posted : April 1, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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) 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 laparoscopic RF ablation (Acessa) 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 (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. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF ablation (Acessa) 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 or disease Intervention/treatment
Uterine Fibroids Procedure: Radiofrequency ablation of fibroids

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Study Start Date : May 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
Women undergoing radiofrequency ablation.
All women in the trial will be in this group who receive treatment with radiofrequency ablation (Acessa).
Procedure: Radiofrequency ablation of fibroids



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of re-intervention for recurrent fibroid symptoms following the Acessa procedure. [ Time Frame: Baseline to 6 weeks ]
  2. 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.

  3. Pregnancy rate after the Acessa procedure. [ Time Frame: Baseline to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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 (Acessa) treatment.
Criteria

Inclusion Criteria:

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

    • Women enrolled at contract clinical sites must enroll prior to their RF ablation treatment

Exclusion Criteria:

  • <21 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100904


Contacts
Contact: Vanessa Monzon 510-999-4326 fibroids@ucsf.edu
Contact: Ruth Gebrezghi 510-999-4326 fibroids@ucsf.edu

Locations
United States, California
University of California, San Francisco Active, not recruiting
San Francisco, California, United States, 94115
United States, Illinois
Gynecology Institute of Chicago Not yet recruiting
Chicago, Illinois, United States, 60605
Contact: Sarah Halfmann    312-929-9191      
Principal Investigator: Nicole Williams, MD         
United States, Texas
UT Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Kimberly Kho, MD         
Principal Investigator: Kimberly A Kho, MD         
MacArthur Medical Center Recruiting
Irving, Texas, United States, 75062
Contact: Jai Fields         
Principal Investigator: Brian Enggano, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02100904     History of Changes
Other Study ID Numbers: 14-13325
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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