Status:
COMPLETED
Uterine Leiomyoma Treatment With Radiofrequency Ablation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of California, Davis
University of California, Irvine
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
21+ years
Phase:
NA
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 invas...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01840124
Start Date
July 1 2013
End Date
January 1 2020
Last Update
January 25 2021
Active Locations (5)
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1
University of California, Davis
Davis, California, United States
2
University of California, Irivine
Irvine, California, United States
3
University of California, San Diego
La Jolla, California, United States
4
University of California, Los Angeles
Los Angeles, California, United States, 90024