Clinical trial NCT01840124: Uterine Leiomyoma Treatment With Radiofrequency Ablation
Official title: Uterine Leiomyoma Treatment With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Keywords: Fibroids
Radiofrequency ablation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: University of California, Irvine
name: University of California, Los Angeles
name: University of California, San Diego
First posted: 2013-04-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in fibroid-related symptoms after the Acessa procedure.
timeFrame: Baseline to 3 years.
Secondary outcomes:
measure: Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
timeFrame: Baseline to 3 years
measure: Operative complications
timeFrame: Baseline to 6 weeks
measure: Pregnancy after the Acessa procedure
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Irvine
country: United States
facility: University of California, Irivine
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Vanessa Jacoby, MD
role: PRINCIPAL_INVESTIGATOR
References: