Radiofrequency Ablation of Adenomyosis

Not Applicable

Recruiting

• Conditions: Adenomyosis
• Interventions: Device: RF Treatment

• Registration Number: NCT05130190
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Study Start: 2022-07-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF Treatment	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.

Primary Outcome Measures

Name	Time	Method
Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis	Day of intervention within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy	Evidence of ablation to be determined through TTC (Triphenyltetrazolium Chloride) staining with presence of a pink-maroon color change indicating functional enzyme activity and absence of color change indicating non-functional enzyme activity

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States