CompletedNot Applicable

Radiofrequency Ablation of Adenomyosis

United States15 participantsStarted 2022-07-14

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis

Timeframe: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)

Trial details

NCT IDNCT05130190

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-22

Results submitted2026-01-22

View on ClinicalTrials.gov More Adenomyosis trials