Radiofrequency Ablation of Adenomyosis

Description

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

Conditions

Adenomyosis

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Study Overview

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Study Details

Study overview

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

RAFA Trial: Radiofrequency Ablation of Adenomyosis

Radiofrequency Ablation of Adenomyosis

Condition
Adenomyosis
Intervention / Treatment

-

Contacts and Locations

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Kimberly Kho, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2025-12