Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA)
The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure.
The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure.
Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with 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. A data safety and monitoring board will oversee participant safety and protection.
Procedure: Radiofrequency ablation of fibroids
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Uterine Leiomyoma Treatment With Radiofrequency Ablation|
- Changes in fibroid-related symptoms after the Acessa procedure. [ Time Frame: Baseline to 3 years. ] [ Designated as safety issue: No ]Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.
- Re-intervention for recurrent fibroid symptoms following the Acessa procedure. [ Time Frame: Baseline to 3 years ] [ 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 after the Acessa procedure [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
All women in the trial will be in this group who receive treatment using the Acessa device.
Procedure: Radiofrequency ablation of fibroids
The Acessa device delivers radiofrequency energy to uterine fibroids to destroy fibroid tissue. The patient undergoes a standard laparoscopy of the pelvis. A laparoscopic ultrasound is performed to identify the precise size and location of the fibroids. The Acessa radiofrequency probe is then placed into the fibroid and the radiofrequency energy is delivered. The fibroid tissue is destroyed and the fibroid shrinks down in size to decrease fibroid-related symptoms.
Other Name: Acessa
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840124
|Contact: Stephanie Lempfirstname.lastname@example.org|
|United States, California|
|University of California, Davis||Recruiting|
|Davis, California, United States|
|Contact: Sarah Steimer email@example.com|
|Principal Investigator: Elaine Waetjen, MD|
|Sub-Investigator: Bahareh Nejad, MD|
|University of California, Irivine||Recruiting|
|Irvine, California, United States|
|Contact: Naghmeh S Saberi, MD 714-456-5694|
|Contact: Mark Vuchinich, MD 714-456-5694|
|Principal Investigator: Naghmeh Saberi, MD|
|Sub-Investigator: Mark Vuchinich, MD|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States|
|Contact: Vanessa Candare 858-657-1299|
|Principal Investigator: Shira Varon, MD|
|Sub-Investigator: Erin Gross, MD|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Ram K Parvatane, MD 310-825-5255 firstname.lastname@example.org|
|Contact: Nicole Pennington 310-794-9652|
|Principal Investigator: Ram K Parvatane, MD|
|Sub-Investigator: Steve Yu, MD|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Stephanie Lemp 415-297-3114 email@example.com|
|Contact: Lisa Abinanti 415-353-9978 firstname.lastname@example.org|
|Principal Investigator: Vanessa Jacoby, MD|
|Sub-Investigator: Alison Jacoby, MD|
|Principal Investigator:||Vanessa Jacoby, MD||University of California, San Francisco|