Radiofrequency Ablation for Adenomyosis
What You Need to Know Before You Apply
What is the purpose of this trial?
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is radiofrequency ablation generally safe for treating adenomyosis and other conditions?
Radiofrequency ablation (RFA) for adenomyosis has shown no major complications in studies, indicating it is generally safe. However, for other conditions like leiomyomas, there have been reports of infections and some cases requiring additional surgery, highlighting the need for careful monitoring.12345
How is radiofrequency ablation treatment different for adenomyosis?
Radiofrequency ablation (RFA) is a minimally invasive treatment that uses high temperatures to target and eliminate diseased tissue in the uterus, offering a uterus-preserving option for women with adenomyosis who want to avoid hysterectomy. Unlike hormonal treatments, RFA directly addresses the tissue causing symptoms like pain and abnormal bleeding, and it has shown promising results in reducing pain and improving quality of life without major complications.12346
What data supports the effectiveness of the treatment for adenomyosis?
Who Is on the Research Team?
Kimberly A Kho, MD
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals planning a hysterectomy due to benign conditions, with confirmed adenomyosis or adenomyomas by MRI. They must be suitable for surgery, able to consent, and speak English. Excluded are those with fibroids near the target area, pregnant or lactating women, under 18s, those with certain uterine devices or requiring emergency/vaginal hysterectomy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Radiofrequency ablation of adenomyosis is performed using the ProVu System during planned hysterectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RF Treatment
RF Treatment is already approved in United States, European Union, China for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Hologic, Inc.
Industry Sponsor