20 Participants Needed

Radiofrequency Ablation for Adenomyosis

KK
Overseen ByKim Kho
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that radiofrequency ablation (RFA) can significantly reduce pain associated with adenomyosis, with a mean decrease in pain scores by about 63% at 12 months. It is a promising minimally invasive treatment that helps improve symptoms without major complications.12347

Who Is on the Research Team?

KK

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

I have adenomyosis or adenomyomas diagnosed by MRI, not on the same side as any fibroids.
Able to provide informed consent
English speaking
See 3 more

Exclusion Criteria

I currently have an infection in my reproductive organs.
I need an urgent hysterectomy.
I have fibroids near my adenomyosis.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Radiofrequency ablation of adenomyosis is performed using the ProVu System during planned hysterectomy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • RF Treatment
Trial Overview The study tests radiofrequency ablation (RF Treatment) on adenomyosis tissue that will be removed during an already planned hysterectomy. The goal is to analyze the treated tissue pathologically to understand the effects of RF treatment on this condition.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: RF TreatmentExperimental Treatment1 Intervention

RF Treatment is already approved in United States, European Union, China for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Radiofrequency Ablation for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Radiofrequency Ablation for:
πŸ‡¨πŸ‡³
Approved in China as Radiofrequency Ablation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Hologic, Inc.

Industry Sponsor

Trials
48
Recruited
59,900+

Published Research Related to This Trial

Transvaginal ultrasound-guided radiofrequency ablation (RFA) for treating symptomatic uterine adenomyosis showed significant effectiveness, with a mean uterine volume reduction of 41.2% after 12 months and a notable decline in dysmenorrhoea and symptom severity scores.
The procedure was found to be safe, with no serious complications reported, although 18.5% of patients required reintervention and two patients developed intrauterine adhesions.
Ultrasound-guided transcervical radiofrequency ablation for symptomatic uterine adenomyosis.Hai, N., Hou, Q., Ding, X., et al.[2019]
In a study of 81 patients with adenomyosis who underwent ultrasound-guided radiofrequency ablation (RFA), 35.8% achieved pregnancy, with a notable 50% success rate among those actively trying to conceive.
RFA not only improved pregnancy outcomes but also significantly reduced menstrual blood loss and pain scores postoperatively, making it a promising minimally-invasive option for patients seeking to maintain fertility and relieve symptoms.
Pregnancy and symptomatic relief following ultrasound-guided transvaginal radiofrequency ablation in patients with adenomyosis.Nam, JH.[2020]
Radiofrequency ablation significantly reduces dysmenorrhea pain in patients with adenomyosis, with an average pain score decrease of 63.4% after 12 months, indicating its efficacy as a treatment.
The procedure is considered safe, as no major complications were reported, making it a promising minimally invasive option for managing symptoms of adenomyosis.
Radiofrequency Ablation for Adenomyosis.Dedes, I., Kolovos, G., Fruscalzo, A., et al.[2023]

Citations

Ultrasound-guided transcervical radiofrequency ablation for symptomatic uterine adenomyosis. [2019]
Pregnancy and symptomatic relief following ultrasound-guided transvaginal radiofrequency ablation in patients with adenomyosis. [2020]
Radiofrequency Ablation for Adenomyosis. [2023]
Heat can treat: long-term follow-up results after uterine-sparing treatment of adenomyosis with radiofrequency thermal ablation in 60 hysterectomy candidate patients. [2022]
Ultrasound-guided transvaginal radiofrequency ablation combined with levonorgestrel-releasing intrauterine system for symptomatic uterine adenomyosis treatment. [2021]
Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. [2023]
Radiofrequency ablation for cystic adenomyosis: a case report. [2006]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security