Uterine Fibroids
Conditions
Keywords
Fibroids, Radiofrequency ablation
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.
Interventions
PROCEDURERadiofrequency 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.
Sponsors
University of California, Davis
University of California, Irvine
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fibroid-related symptoms after the Acessa procedure. | Baseline to 3 years. | Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-intervention for recurrent fibroid symptoms following the Acessa procedure. | Baseline to 3 years | — |
| Operative complications | Baseline to 6 weeks | 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 | Baseline to 3 years | — |
Countries
United States
Outcome results
None listed