Trial Outcomes & Findings for Radiofrequency Ablation of Adenomyosis (NCT NCT05130190)

Last Updated: 2026-03-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)

Results posted on

2026-03-20

Participant Flow

Participants recruited in gynecology clinic who were planning to undergo hysterectomy for MRI confirmed adenomyosis over 30 months.

1 patient withdrew consent prior to the hysterectomy

Participant milestones

Participant milestones
Measure	RF Treatment 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.
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	RF Treatment 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.
Overall Study Withdrawal by Subject	1
Overall Study Pathology Team Not Available	2
Overall Study Physician Decision	1

Baseline Characteristics

Radiofrequency Ablation of Adenomyosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RF Treatment n=15 Participants 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.
Age, Continuous	40.9 years STANDARD_DEVIATION 7.6 • n=154 Participants
Sex: Female, Male Female	15 Participants n=154 Participants
Sex: Female, Male Male	0 Participants n=154 Participants
Race/Ethnicity, Customized White	6 Participants n=154 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=154 Participants
Race/Ethnicity, Customized African-American	1 Participants n=154 Participants
Race/Ethnicity, Customized Asian	2 Participants n=154 Participants
Race/Ethnicity, Customized Other/Unknown	4 Participants n=154 Participants
BMI	27.6 kg/m^2 STANDARD_DEVIATION 6.3 • n=154 Participants
Gravity	2 pregnancies STANDARD_DEVIATION 2.8 • n=154 Participants

PRIMARY outcome

Timeframe: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)

Population: A total number of anatomic treated areas contributed by participants in this arm were evaluated. Each area was examined microscopically and categorized as 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.

Outcome measures

Outcome measures
Measure	RF Treatment n=19 treated areas 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. RF Treatment: 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.
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis Treated areas with no adenomyois identified microscopically	9 treated areas
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis Treated areas with definitive thermal artifact on serosa	8 treated areas
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis Treated areas with documented thermal artifact on endometrium	7 treated areas
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis Dilated, prominent more thick-walled / small ectatic vessels with thermal artifact on or around them	6 treated areas
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis Treated areas with adenomyosis identified microscopically	10 treated areas

Adverse Events

RF Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kimberly Kho MD

John A. Burns School of Medicine, University of Hawai'i at Mānoa

Phone: 7133203177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place