NCT05130190

Radiofrequency Ablation of Adenomyosis

RAFA Trial: Radiofrequency Ablation of Adenomyosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-07-14
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2021-11-23
• Last updated: 2026-03-20
• Results posted: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study