Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry|
- 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.
- 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 ]
|Study Start Date:||May 2014|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02100904
|Contact: Vanessa Monzonfirstname.lastname@example.org|
|Contact: Lynette Gonzalezemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Vanessa Monzon 415-297-3114 firstname.lastname@example.org|
|Contact: Lynette Gonzalez 415-297-3114 email@example.com|
|Principal Investigator: Vanessa Jacoby, MD|
|Principal Investigator:||Vanessa Jacoby, MD||University of California, San Francisco|