Radiofrequency Ablation of Adenomyosis

NCT05130190 | Completed Results FDA Device

• 1 other identifier: STU-2021-0741
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.

Conditions

Adenomyosis

Keywords

adenomyosis; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

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.

Device: RF Treatment

Interventions

RF Treatment DEVICE

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.

Also known as: ProVu System

RF Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Hologic, Inc.: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

This was a small study on the effects of RF technology on adenomyosis specimens.

Results Point of Contact

• Title: Kimberly Kho MD
• Organization: John A. Burns School of Medicine, University of Hawai'i at Mānoa

kimberly.kho@hphmg.org

7133203177

Study Officials

• Kimberly Kho, MD

  Hawaii Pacific Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics & Gynecology

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: July 14, 2022
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)