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The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).
The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.
UC San Francisco will have 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women undergoing radiofrequency ablation. | Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa). |
| |
| Women undergoing myomectomy | About 25% of women in the trial will be in the group who receive treatment with myomectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation of fibroids | Procedure |
| ||
| Myomectomy of fibroids |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fibroid-related symptoms after the RFA or myomectomy procedure. | We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life. | Baseline to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. | Baseline to 6 weeks | |
| Operative complications | 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. |
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Inclusion Criteria:
Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.
Able to give informed consent
Speak English or Spanish
Exclusion Criteria:
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Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Jacoby, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Medical Center | Irvine | California | 92868 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37023398 | Derived | Rubio EM, Hilton JF, Bent S, Parvataneni R, Oberman E, Saberi NS, Varon S, Schembri M, Waetjen LE, Jacoby VL. Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids. J Womens Health (Larchmt). 2023 May;32(5):546-552. doi: 10.1089/jwh.2022.0094. Epub 2023 Apr 6. |
| Label | URL |
|---|---|
| Fibroid Trials at UCSF | View source |
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| Procedure |
|
| Baseline to 6 weeks |
| Pregnancy rate after the RFA or myomectomy procedure. | Baseline to 3 years |
| San Diego |
| California |
| 92037 |
| United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| Dedicated to Women | Dover | Delaware | 19904 | United States |
| Fibroid and Pelvic Wellness Center of Georgia | Alpharetta | Georgia | 30005 | United States |
| Gynecology Institute of Chicago | Chicago | Illinois | 60605 | United States |
| Women's Healthcare Associates of IL, SC | Homewood | Illinois | 60430 | United States |
| Duke University | Durham | North Carolina | 27704 | United States |
| Tassone Advanced Gynecology | Austin | Texas | 78723 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| MacArthur Medical Center | Irving | Texas | 75062 | United States |
| Acacia OBGYN | San Antonio | Texas | 78217 | United States |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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