Uterine Leiomyoma Treatment With Radiofrequency Ablation

NCT01840124 | Completed DMC

• 1 other identifier: 13-11026
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

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.

Conditions

Uterine Fibroids

Keywords

Fibroids; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 3 years.

Secondary Outcomes (3)

• Re-intervention for recurrent fibroid symptoms following the Acessa procedure.

  Baseline to 3 years

• Operative complications

  Baseline to 6 weeks

• Pregnancy after the Acessa procedure

  Baseline to 3 years

Study Arms (1)

Acessa

EXPERIMENTAL

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

Procedure: Radiofrequency ablation of fibroids

Interventions

Radiofrequency ablation of fibroids PROCEDURE

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.

Also known as: Acessa

Acessa

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

University of California, Davis

Davis, California, United States

Location

University of California, Irivine

Irvine, California, United States

Location

University of California, San Diego

La Jolla, California, United States

Location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Links

• Fibroid Trials at UCSF

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Vanessa Jacoby, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 25, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (5)