Uterine Leiomyoma Treatment With Radiofrequency Ablation

Not Applicable

Completed

• Conditions: Uterine Fibroids
• Interventions: Procedure: Radiofrequency ablation of fibroids

• Registration Number: NCT01840124
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2013-07
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acessa	Radiofrequency ablation of fibroids	All women in the trial will be in this group who receive treatment using the Acessa device.

Primary Outcome Measures

Name	Time	Method
Changes in fibroid-related symptoms after the Acessa procedure.	Baseline to 3 years.	Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.

Secondary Outcome Measures

Name	Time	Method
Re-intervention for recurrent fibroid symptoms following the Acessa procedure.	Baseline to 3 years
Operative complications	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 after the Acessa procedure	Baseline to 3 years

Trial Locations

Locations (5)

University of California, Davis; 🇺🇸 Davis, California, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

University of California, Irivine; 🇺🇸 Irvine, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States