ULTRA: Uterine Leiomyoma Treatment With Radiofrequency Ablation

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01840124
Collaborator
University of California, Davis (Other), University of California, Irvine (Other), University of California, Los Angeles (Other), University of California, San Diego (Other)
26
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency ablation of fibroids
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Uterine Leiomyoma Treatment With Radiofrequency Ablation
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acessa

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 Names:
  • Acessa
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Re-intervention for recurrent fibroid symptoms following the Acessa procedure. [Baseline to 3 years]

    2. 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.

    3. Pregnancy after the Acessa procedure [Baseline to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Davis Davis California United States
    2 University of California, Irivine Irvine California United States
    3 University of California, San Diego La Jolla California United States
    4 University of California, Los Angeles Los Angeles California United States 90024
    5 University of California, San Francisco San Francisco California United States 94115

    Sponsors and Collaborators

    • University of California, San Francisco
    • University of California, Davis
    • University of California, Irvine
    • University of California, Los Angeles
    • University of California, San Diego

    Investigators

    • Principal Investigator: Vanessa Jacoby, MD, University of California, San Francisco

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT01840124
    Other Study ID Numbers:
    • 13-11026
    First Posted:
    Apr 25, 2013
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by University of California, San Francisco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2021