Overview

This trial is active, not recruiting.

Condition uterine fibroids
Treatment radiofrequency ablation of fibroids
Phase phase 4
Sponsor University of California, San Francisco
Collaborator University of California, Davis
Start date July 2013
End date June 2017
Trial size 100 participants
Trial identifier NCT01840124, 13-11026

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All women in the trial will be in this group who receive treatment using the Acessa device.
radiofrequency ablation of fibroids Acessa
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
time frame: Baseline to 3 years
Operative complications
time frame: Baseline to 6 weeks
Pregnancy after the Acessa procedure
time frame: Baseline to 3 years

Eligibility Criteria

Female participants at least 21 years old.

INCLUSION CRITERIA 1. Premenopausal (at least 1 menstrual period in last 3 months) 2. Age >21years 3. Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia 4. Desires surgical management of fibroids 5. Uterus ≤16 weeks in size 6. All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year. 7. Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study "Fibroids" will be leiomyomas > 2cm) 8. Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities 9. Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) 10. Able to tolerate laparoscopic surgery 11. Able to give informed consent EXCLUSION CRITERIA 1. Planned treatment for infertility 2. Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) 3. Intracavitary (FIGO Type 0) fibroid 4. Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary) 5. Planned concomitant surgical procedure in addition to treatment of uterine fibroids 6. Use of Essure or any other metallic, implantable device within pelvis 7. Pregnancy 8. Pelvic infection with the last 3 months 9. History of pelvic malignancy and/or pelvic radiation 10. Known or high suspicion for dense pelvic adhesions 11. Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months

Additional Information

Official title Uterine Leiomyoma Treatment With Radiofrequency Ablation
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.