AdenomyosisNCT05130190
Radiofrequency Ablation of Adenomyosis
A study testing RF Treatment in people with Adenomyosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- RF Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy due to benign conditions
- uterus < 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
- at least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI
- able to provide informed consent
- suitable candidates for surgery (have passed a standard pre-operative health assessment)
- English speaking
Who cannot join
- require emergent hysterectomy or vaginal hysterectomy
- have a uterus > 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
- have fibroids in the proximity of the target adenomyosis (same side, similar location)
- are not appropriate surgical candidates as determined during pre-operative health assessment
- are unable or unwilling to undergo a hysterectomy
- are pregnant or lactating
Show all 12Show fewer
- are under the age of 18 years
- have active pelvic inflammatory disease
- have a history of gynecologic malignancy within the past 3 years
- are unable to give informed consent
- have an implantable uterine or fallopian tube device for contraception
- are not English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: RAFA Trial: Radiofrequency Ablation of Adenomyosis
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Read the detailed description
The ProVu™ System (Hologic, Inc., Boston, MA) is designed and cleared by the FDA as a treatment method for soft tissue, including the treatment of symptomatic uterine fibroids. After locating the general region of the target tissue, a laparoscopic ultrasound transducer is placed on the serosal surface of the uterus to identify the size, location, and number of focal adenomyosis (or adenomyomas). Under ultrasound guidance, the treatment probe (handpiece) is inserted through the serosal surface and into the target tissue. The electrode array containing multiple thermocouples is then deployed according to the size of the target tissue and the position is verified using the ultrasound transducer. Once correctly placed, the surgeon initiates ablation by pressing the foot pedal. Continuous temperature feedback is displayed on the generator screen. For safety purposes, dispersive pads are placed on the patient's thighs to disperse electrical current. If the target tissue is irregular or large, the needle array is retracted and the probe repositioned within the same area under ultrasound guidance. The ablation is repeated until the area of interest is ablated. Overlapping ablations may be required. At the conclusion of the final ablation, the surgeon retracts the array withdraws the probe through the serosal surface of the uterus while coagulating the track to avoid bleeding. Once hemostasis is confirmed and all target tissue has been treated, the surgeon proceeds with the planned hysterectomy and the tissue is examined by a pathologist to assess the ablation zones within the adenomyoma or focal adenomyosis.
- Conditions
- Adenomyosis
- Being tested
- RF Treatment
- Keywords
- adenomyosis, radiofrequency ablation
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF TreatmentDevice
Also called ProVu System
ProVu treatment probe will be energized and RF energy delivered in a pre-programmed, controlled method based on the predetermined size of the affected tissue.
| Study group | Role | What they receive |
|---|---|---|
| RF Treatment | Other | At the time of the subject's trans-abdominal or laparoscopic hysterectomy, the ProVu System will be used to apply RF treatment to one or two adenomas, focal areas of adenomyosis, or diffuse adenomyosis. Receives: Device: RF Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis
Participants who provided at least one post-ablation tissue area for histological evaluation are included in the analysis population. The unit of analysis for this outcome is the individual tissue area (specimen/region). Each area is examined by a pathologist and assigned to one of categories: Treated areas with no adenomyois noted; Treated areas with definitive thermal artifact on serosa; Treated areas with documented thermal artifact on endometrium; Dilated, prominent more thick-walled / small ectatic vessels with thermal artifact on or around them; and Treated areas with adenomyosis identified microscopically. Counts in the results table are based on the total number of evaluated areas within each group.
Measured: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start14 Jul 2022
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Principal investigator, Katherine Smith, University of Texas Southwestern Medical Center
- Investigators
- Kimberly Kho, MD, Study director, Hawaii Pacific Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130190
- Sponsor's protocol ID
- STU-2021-0741
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2021
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAFA Trial: Radiofrequency Ablation of Adenomyosis
- ClinicalTrials.gov ID
- NCT05130190
- Acronym / sponsor ID
- STU-2021-0741
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Detailed description
The ProVu™ System (Hologic, Inc., Boston, MA) is designed and cleared by the FDA as a treatment method for soft tissue, including the treatment of symptomatic uterine fibroids. After locating the general region of the target tissue, a laparoscopic ultrasound transducer is placed on the serosal surface of the uterus to identify the size, location, and number of focal adenomyosis (or adenomyomas). Under ultrasound guidance, the treatment probe (handpiece) is inserted through the serosal surface and into the target tissue. The electrode array containing multiple thermocouples is then deployed according to the size of the target tissue and the position is verified using the ultrasound transducer. Once correctly placed, the surgeon initiates ablation by pressing the foot pedal. Continuous temperature feedback is displayed on the generator screen. For safety purposes, dispersive pads are placed on the patient's thighs to disperse electrical current. If the target tissue is irregular or large, the needle array is retracted and the probe repositioned within the same area under ultrasound guidance. The ablation is repeated until the area of interest is ablated. Overlapping ablations may be required. At the conclusion of the final ablation, the surgeon retracts the array withdraws the probe through the serosal surface of the uterus while coagulating the track to avoid bleeding. Once hemostasis is confirmed and all target tissue has been treated, the surgeon proceeds with the planned hysterectomy and the tissue is examined by a pathologist to assess the ablation zones within the adenomyoma or focal adenomyosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Treatment | Other | Device: RF TreatmentAt the time of the subject's trans-abdominal or laparoscopic hysterectomy, the ProVu System will be used to apply RF treatment to one or two adenomas, focal areas of adenomyosis, or diffuse adenomyosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy due to benign conditions
- uterus < 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
- at least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI
- able to provide informed consent
- suitable candidates for surgery (have passed a standard pre-operative health assessment)
Key exclusion criteria (12 listed)
- require emergent hysterectomy or vaginal hysterectomy
- have a uterus > 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
- have fibroids in the proximity of the target adenomyosis (same side, similar location)
- are not appropriate surgical candidates as determined during pre-operative health assessment
- are unable or unwilling to undergo a hysterectomy
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 |
|---|---|---|
| RF TreatmentAlso: ProVu SystemProVu treatment probe will be energized and RF energy delivered in a pre-programmed, controlled method based on the predetermined size of the affected tissue. | Device | RF Treatment |
Primary outcome
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis
Time frame: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)
Participants who provided at least one post-ablation tissue area for histological evaluation are included in the analysis population. The unit of analysis for this outcome is the individual tissue area (specimen/region). Each area is examined by a pathologist and assigned to one of categories: Treated areas with no adenomyois noted; Treated areas with definitive thermal artifact on serosa; Treated areas with documented thermal artifact on endometrium; Dilated, prominent more thick-walled / small ectatic vessels with thermal artifact on or around them; and Treated areas with adenomyosis identified microscopically. Counts in the results table are based on the total number of evaluated areas within each group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kimberly Kho, MD study director
Hawaii Pacific Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Treatment in people with Adenomyosis, run by University of Texas Southwestern Medical Center at 1 site 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 6 inclusion and 12 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis (time frame: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)). 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 20 Mar 2026.