Radiofrequency Ablation of Adenomyosis

  • End date
    Feb 24, 2024
  • participants needed
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 4 October 2022


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


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.

Condition Adenomyosis
Treatment RF Treatment
Clinical Study IdentifierNCT05130190
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on4 October 2022


Yes No Not Sure

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
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