Radiofrequency Ablation of Adenomyosis

NCT ID: NCT05130190

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2025-01-22

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

RF Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ProVu System

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Katherine Smith

Assistant Professor of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly Kho, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2021-0741

Identifier Type: -

Identifier Source: org_study_id