Radiofrequency Ablation of Adenomyosis

Last updated: April 11, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Dysfunctional Uterine Bleeding

Treatment

RF Treatment

Clinical Study ID

NCT05130190
STU-2021-0741
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy dueto 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/arecontralateral to any fibroids as determined by MRI

  • able to provide informed consent

  • suitable candidates for surgery (have passed a standard pre-operative healthassessment)

  • English speaking

Exclusion

Exclusion Criteria:

  • require emergent hysterectomy or vaginal hysterectomy

  • have a uterus > 16 weeks gestational size if undergoing a laparoscopic or roboticprocedure (no size limit for patients planning to undergo a transabdominalhysterectomy)

  • have fibroids in the proximity of the target adenomyosis (same side, similarlocation)

  • are not appropriate surgical candidates as determined during pre-operative healthassessment

  • 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: RF Treatment
Phase:
Study Start date:
July 14, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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