Uterine Leiomyoma Treatment With Radiofrequency Ablation

NCT ID: NCT01840124

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acessa

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

Group Type: EXPERIMENTAL

Radiofrequency ablation of fibroids

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Acessa

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Jacoby, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, Davis

Davis, California, United States

University of California, Irivine

Irvine, California, United States

University of California, San Diego

La Jolla, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.ucsf.edu/fibroids

Fibroid Trials at UCSF

Other Identifiers

13-11026

Identifier Type: -

Identifier Source: org_study_id