Radiofrequency Ablation of Adenomyosis

Adenomyosis Clinical Trial

Official title:

RAFA Trial: Radiofrequency Ablation of Adenomyosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130190
• Other study ID #: STU-2021-0741
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis	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	Day of intervention within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy