Using radiofrequency ablation to treat adenomyosis
RAFA Trial: Radiofrequency Ablation of Adenomyosis
This study is testing if using radiofrequency energy to remove adenomyosis tissue during a hysterectomy can improve outcomes and safety for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05130190 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of radiofrequency ablation on adenomyosis by analyzing the tissue removed during planned hysterectomy. The ProVu™ System is utilized to precisely locate and ablate the affected tissue under ultrasound guidance. The procedure involves inserting a treatment probe into the target area and applying controlled radiofrequency energy to destroy the adenomyosis tissue. The study will assess the outcomes and safety of this innovative approach for patients undergoing hysterectomy for benign conditions.
Who should consider this trial
Good fit: Ideal candidates are women planning to undergo a hysterectomy for benign conditions with diagnosed adenomyosis.
Not a fit: Patients requiring emergent or vaginal hysterectomy, or those with fibroids near the adenomyosis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing adenomyosis, potentially improving patient outcomes and quality of life.
How similar studies have performed: Other studies have shown promising results with radiofrequency ablation for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Kho, MD — UT Southwestern Medical Center
- Study coordinator: Kim Kho
- Email: kimberly.kho@utsouthwestern.edu
- Phone: 214-645-3888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.