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Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA)

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency ablation of fibroids
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Fibroids, Radiofrequency ablation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acessa

Arm Description

All women in the trial will be in this group who receive treatment using the Acessa device.

Outcomes

Primary Outcome Measures

Changes in fibroid-related symptoms after the Acessa procedure.
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.
Operative complications
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

Full Information

First Posted
April 17, 2013
Last Updated
January 21, 2021
Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01840124
Brief Title
Uterine Leiomyoma Treatment With Radiofrequency Ablation
Acronym
ULTRA
Official Title
Uterine Leiomyoma Treatment With Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Fibroids, Radiofrequency ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acessa
Arm Type
Experimental
Arm Description
All women in the trial will be in this group who receive treatment using the Acessa device.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation of fibroids
Other Intervention Name(s)
Acessa
Intervention Description
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 Outcome Measure Information:
Title
Changes in fibroid-related symptoms after the Acessa procedure.
Description
Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.
Time Frame
Baseline to 3 years.
Secondary Outcome Measure Information:
Title
Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
Time Frame
Baseline to 3 years
Title
Operative complications
Description
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.
Time Frame
Baseline to 6 weeks
Title
Pregnancy after the Acessa procedure
Time Frame
Baseline to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA Premenopausal (at least 1 menstrual period in last 3 months) Age >21years Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia Desires surgical management of fibroids Uterus ≤16 weeks in size All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year. Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study "Fibroids" will be leiomyomas > 2cm) Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) Able to tolerate laparoscopic surgery Able to give informed consent EXCLUSION CRITERIA Planned treatment for infertility Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) Intracavitary (FIGO Type 0) fibroid Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary) Planned concomitant surgical procedure in addition to treatment of uterine fibroids Use of Essure or any other metallic, implantable device within pelvis Pregnancy Pelvic infection with the last 3 months History of pelvic malignancy and/or pelvic radiation Known or high suspicion for dense pelvic adhesions Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Jacoby, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
Country
United States
Facility Name
University of California, Irivine
City
Irvine
State/Province
California
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.ucsf.edu/fibroids
Description
Fibroid Trials at UCSF

Learn more about this trial

Uterine Leiomyoma Treatment With Radiofrequency Ablation

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