Radiofrequency Ablation of Adenomyosis

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Brief Title

Radiofrequency Ablation of Adenomyosis

Official Title

RAFA Trial: Radiofrequency Ablation of Adenomyosis

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 Type

Interventional


Primary Outcome

Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis


Condition

Adenomyosis

Intervention

RF Treatment

Study Arms / Comparison Groups

 RF Treatment
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

July 14, 2022

Completion Date

February 2024

Primary Completion Date

October 2023

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kimberly Kho, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05130190

Organization ID

STU-2021-0741


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center

Collaborators

 Hologic, Inc.

Study Sponsor

Kimberly Kho, MD, Principal Investigator, UT Southwestern Medical Center


Verification Date

July 2022