Clinical Trial: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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) 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.


Detailed Summary:
Sponsor: University of California, San Francisco

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: March 27, 2014
Date Started: May 2014
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017