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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

Tracking Information
First Submitted Date  ICMJE November 10, 2021
First Posted Date  ICMJE November 23, 2021
Last Update Posted Date July 14, 2022
Actual Study Start Date  ICMJE July 14, 2022
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2022)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2021)		 Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis [ Time Frame: Day of intervention within 4 hours of RF treatment and 2 hours of completion of hysterectomy ]
Evidence of ablation to be determined through TTC staining with presence of a pink-maroon color change indicating functional enzyme activity and absence of color change indicating non-functional enzyme activity
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiofrequency Ablation of Adenomyosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Adenomyosis
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: RF Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2021)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05130190
Other Study ID Numbers  ICMJE STU-2021-0741
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kimberly Kho, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hologic, Inc.
Investigators  ICMJE
Principal Investigator: Kimberly Kho, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP