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Radiofrequency Ablation of Adenomyosis

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Conditions

Adenomyosisradiofrequency ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

RAFA Trial: Radiofrequency Ablation of Adenomyosis

Quick Facts

Study Start:2022-07-14
Study Completion:2025-01-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05130190

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy due to benign conditions
  2. * uterus \< 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
  3. * at least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI
  4. * able to provide informed consent
  5. * suitable candidates for surgery (have passed a standard pre-operative health assessment)
  6. * English speaking
  1. * require emergent hysterectomy or vaginal hysterectomy
  2. * 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)
  3. * have fibroids in the proximity of the target adenomyosis (same side, similar location)
  4. * are not appropriate surgical candidates as determined during pre-operative health assessment
  5. * are unable or unwilling to undergo a hysterectomy
  6. * are pregnant or lactating
  7. * are under the age of 18 years
  8. * have active pelvic inflammatory disease
  9. * have a history of gynecologic malignancy within the past 3 years
  10. * are unable to give informed consent
  11. * have an implantable uterine or fallopian tube device for contraception
  12. * are not English speaking

Contacts and Locations

Principal Investigator

Kimberly Kho, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Kimberly Kho, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-14
Study Completion Date2025-01-22

Study Record Updates

Study Start Date2022-07-14
Study Completion Date2025-01-22

Terms related to this study

Keywords Provided by Researchers

  • adenomyosis
  • radiofrequency ablation

Additional Relevant MeSH Terms

  • Adenomyosis