Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, San Francisco
Sponsor:
Collaborators:
University of California, Davis
University of California, Irvine
University of California, Los Angeles
University of California, San Diego
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01840124
First received: April 17, 2013
Last updated: May 29, 2014
Last verified: May 2014

April 17, 2013
May 29, 2014
July 2013
June 2017   (final data collection date for primary outcome measure)
Changes in fibroid-related symptoms after the Acessa procedure. [ Time Frame: Baseline to 3 years. ] [ Designated as safety issue: No ]
We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.
Same as current
Complete list of historical versions of study NCT01840124 on ClinicalTrials.gov Archive Site
  • Rate of 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 rate after the Acessa procedure [ Time Frame: Baseline to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Uterine Leiomyoma Treatment With Radiofrequency Ablation
Uterine Leiomyoma Treatment With Radiofrequency Ablation

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Fibroids
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
Experimental: Acessa
All women in the trial will be in this group who receive treatment using the Acessa device.
Intervention: Procedure: Radiofrequency ablation of fibroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
June 2017   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact: Lisa Abinanti 415-353-9978 lisa.abinanti@ucsf.edu
United States
 
NCT01840124
13-11026
Yes
University of California, San Francisco
University of California, San Francisco
  • University of California, Davis
  • University of California, Irvine
  • University of California, Los Angeles
  • University of California, San Diego
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
University of California, San Francisco
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP