This trial is active, not recruiting.

Condition uterine fibroids
Treatment radiofrequency ablation of fibroids
Sponsor University of California, San Francisco
Start date May 2014
End date June 2019
Trial size 100 participants
Trial identifier NCT02100904, 14-13325


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
All women in the trial will be in this group who receive treatment with radiofrequency ablation (Acessa).
radiofrequency ablation of fibroids

Primary Outcomes

Changes in fibroid-related symptoms after the Acessa procedure.
time frame: Baseline to 3 years

Secondary Outcomes

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
Pregnancy rate after the Acessa procedure.
time frame: Baseline to 3 years

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Planning to undergo or have undergone RF ablation (Acessa) for treatment of uterine fibroids. - Able to give informed consent Exclusion Criteria: - <21 years of age

Additional Information

Official title Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Principal investigator Vanessa Jacoby, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.