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Radiofrequency Ablation of Adenomyosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130190
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Kimberly Kho, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenomyosis Device: RF Treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: RAFA Trial: Radiofrequency Ablation of Adenomyosis
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : February 2024
Arms and Interventions
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Arm Intervention/treatment
RF Treatment
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.
 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.
Other Name: ProVu System


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis [ Time Frame: Day of intervention within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130190


Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Marisa Latham, BSN    214-762-6221    marisa.latham@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Hologic, Inc.
Investigators
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Principal Investigator: Kimberly Kho, MD UT Southwestern Medical Center
More Information
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Responsible Party: Kimberly Kho, Associate Professor of Obstetrics & Gynecology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05130190    
Other Study ID Numbers: STU-2021-0741
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kimberly Kho, University of Texas Southwestern Medical Center:
adenomyosis
radiofrequency ablation
Additional relevant MeSH terms:
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Adenomyosis
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases