Uterine FibroidsULTRANCT01840124
Uterine Leiomyoma Treatment With Radiofrequency Ablation
A study testing Radiofrequency ablation of fibroids in people with Uterine Fibroids, run by University of California, San Francisco at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Radiofrequency ablation of fibroids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2013to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of California, Davis
Davis, California
University of California, Irivine
Irvine, California
University of California, San Diego
La Jolla, California
University of California, Los Angeles
Los Angeles, California, 90024
University of California, San Francisco
San Francisco, California, 94115
About this study
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
- Being tested
- Radiofrequency ablation of fibroids
- Keywords
- Fibroids, Radiofrequency ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of fibroidsProcedure or surgery
Also called Acessa
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.
| Study group | Role | What they receive |
|---|---|---|
| Acessa | Experimental | All women in the trial will be in this group who receive treatment using the Acessa device. Receives: Procedure: Radiofrequency ablation of fibroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fibroid-related symptoms after the Acessa procedure.
Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.
Measured: Baseline to 3 years.
Secondary outcomes (3)
Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
Measured: Baseline to 3 years
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.
Measured: Baseline to 6 weeks
Pregnancy after the Acessa procedure
Measured: Baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840124
- Sponsor's protocol ID
- 13-11026
- Acronym
- ULTRA
- Status last verified
- Jan 2021
- First submitted
- 17 Apr 2013
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Leiomyoma Treatment With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT01840124
- Acronym / sponsor ID
- ULTRA / 13-11026
- Conditions
- Uterine Fibroids
- Keywords
- Fibroids, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Diego
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acessa | Experimental | Procedure: Radiofrequency ablation of fibroidsAll women in the trial will be in this group who receive treatment using the Acessa device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation of fibroidsAlso: AcessaThe 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. | Procedure or surgery | Acessa |
Primary outcome
Changes in fibroid-related symptoms after the Acessa procedure.
Time frame: Baseline to 3 years.
Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.
3 secondary outcomes
Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
Time frame: Baseline to 3 years
Operative complications
Time frame: Baseline to 6 weeks
Pregnancy after the Acessa procedure
Time frame: Baseline to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Fibroid Trials at UCSFLink provided by the sponsor.
Related trials for Uterine Fibroids
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Jacoby, MD principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of fibroids in people with Uterine Fibroids, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fibroid-related symptoms after the Acessa procedure. (time frame: Baseline to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.