Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 13, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Uterine Fibroids
Procedure: Radiofrequency ablation of fibroids
Phase 4

Study Type: Interventional
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Acessa

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840124

Contacts
Contact: Lisa Abinanti 415-353-9978 lisa.abinanti@ucsf.edu

Locations
United States, California
University of California, Davis Recruiting
Davis, California, United States
Contact: Sarah Steimer       sarah.steimer@ucdmc.ucdavis.edu   
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    uclaobgynresearch@mednet.ucla.edu   
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    lemps@obgyn.ucsf.edu   
Contact: Lisa Abinanti    415-353-9978    lisa.abinanti@ucsf.edu   
Principal Investigator: Vanessa Jacoby, MD         
Sub-Investigator: Alison Jacoby, MD         
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01840124     History of Changes
Other Study ID Numbers: 13-11026
Study First Received: April 17, 2013
Last Updated: August 13, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Fibroids
Radiofrequency ablation

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 30, 2014