Radiofrequency Ablation for Adenomyosis

Overseen By Kim Kho

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Gynecologic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how radiofrequency ablation, a technique using heat to treat tissue, affects adenomyosis—a condition where the inner lining of the uterus breaks through the muscle wall. Researchers will treat specific areas of adenomyosis before a planned hysterectomy and then study the removed tissue. This trial targets individuals planning a hysterectomy for non-cancerous reasons, diagnosed with adenomyosis separate from any fibroids. Participants must understand and speak English and have medical clearance for surgery. As an unphased trial, this study offers a unique opportunity to advance understanding of a new treatment approach for adenomyosis.

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.

What prior data suggests that radiofrequency ablation is safe for treating adenomyosis?

Research has shown that radiofrequency ablation (RFA) for adenomyosis is generally safe. In a study with 1,049 patients, 83.1% reported symptom improvement. Importantly, the chance of a serious side effect was low.

Other studies have found that the need for another procedure ranged from 1.6% to 39.5%. Of these, only 1.6% to 9.9% required another treatment soon after. This suggests that most patients handle RFA well.

Additionally, experts state that surgeons can learn to perform RFA safely, supporting its potential as a safe treatment option for those with adenomyosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for adenomyosis, which often include hormonal therapies or surgery, the RF Treatment stands out because it uses radiofrequency ablation to target the condition directly. This method involves applying radiofrequency energy to the affected areas, offering a minimally invasive alternative that could reduce recovery time and lower the risk of complications compared to traditional surgical options. Researchers are excited about this approach because it has the potential to provide effective relief with less disruption to patients' lives.

What evidence suggests that radiofrequency ablation is effective for adenomyosis?

Research has shown that radiofrequency ablation (RFA), which participants in this trial will receive, effectively treats adenomyosis, a painful uterine condition. In a study with 1,049 patients, 83.1% experienced symptom improvement after RFA treatment. Additionally, RFA significantly shrank the affected areas. Specifically, another study found that the uterus size decreased by about 41.2% within a year after treatment. These findings suggest that RFA can safely and effectively manage adenomyosis symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Kimberly A Kho, MD

Principal Investigator

University of Texas 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

Exclusion Criteria

I currently have an infection in my reproductive organs.

I need an urgent hysterectomy.

I have fibroids near my adenomyosis.

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?

Group I: RF Treatment Experimental Treatment 1 Intervention

At the time of the subject's trans-abdominal or laparoscopic hysterectomy, the ProVu System will be used to apply RF treatment to one or two adenomas, focal areas of adenomyosis, or diffuse adenomyosis.

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

Approved in United States as Radiofrequency Ablation for:

• Uterine fibroids
• Adenomyosis-related heavy bleeding and pain

Approved in European Union as Radiofrequency Ablation for:

• Uterine fibroids

Approved in China as Radiofrequency Ablation for:

• Adenomyosis-related heavy bleeding and pain

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation for Adenomyosis. Dedes, I., Kolovos, G., Fruscalzo, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and symptomatic relief following ultrasound-guided transvaginal radiofrequency ablation in patients with adenomyosis. Nam, JH.[2020]

Radiofrequency thermal ablation (RFA) is an effective uterine-sparing treatment for patients with adenomyosis, significantly reducing pain and other symptoms, with only 13% of patients requiring hysterectomy after treatment.

In a study of 60 patients over a mean follow-up of 56 months, RFA led to substantial improvements in pain scores (e.g., dysmenorrhea decreased from 7.4 to 3.3) and resolved bulk symptoms in all cases, demonstrating its efficacy as an alternative to hysterectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat can treat: long-term follow-up results after uterine-sparing treatment of adenomyosis with radiofrequency thermal ablation in 60 hysterectomy candidate patients. Stepniewska, AK., Baggio, S., Clarizia, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transcervical radiofrequency ablation for symptomatic uterine adenomyosis. Hai, N., Hou, Q., Ding, X., et al.[2019]

A study analyzing 60 reports from the FDA's MAUDE database on radiofrequency ablation (RFA) for leiomyomas found that the most common adverse event was infection, highlighting potential safety concerns with this treatment.

Of the injury cases reviewed, 34.9% required additional surgical intervention, indicating that while RFA is a novel treatment option, there are significant risks that necessitate careful monitoring and postmarket surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. Young, RJ., Puma, L., Latham, M., et al.[2023]

In a study of 72 patients with symptomatic uterine adenomyosis, those treated with transvaginal ultrasound-guided radiofrequency ablation (RFA) combined with a levonorgestrel-releasing intrauterine system (LNG-IUS) showed a significant average uterine volume reduction of 55% over a 3-year follow-up period.

The combined treatment resulted in statistically significant decreases in dysmenorrhea and overall symptom severity, with no reported expulsions of the LNG-IUS, indicating both safety and efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transvaginal radiofrequency ablation combined with levonorgestrel-releasing intrauterine system for symptomatic uterine adenomyosis treatment. Hai, N., Hou, Q., Guo, R.[2021]

A 21-year-old woman with cystic adenomyosis underwent successful radiofrequency ablation, which was completed in about 15 minutes without complications, marking the first reported case of this treatment for the condition.

Post-procedure, the patient experienced a significant reduction in dysmenorrhea severity by one-third, indicating that radiofrequency ablation may be an effective and minimally invasive option for treating cystic adenomyosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation for cystic adenomyosis: a case report. Ryo, E., Takeshita, S., Shiba, M., et al.[2006]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10179480/

Radiofrequency Ablation for Adenomyosis - PMC

After data-synthesis of 1049 patients, they were able to show an improvement of symptoms in 83.1% of patients [27]. Our review revealed sparse ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1553465022004629

Radiofrequency Ablation for Treatment of Adenomyosis

The currently available data suggest that RFA can be a safe and effective treatment for adenomyosis, causing volumetric reduction in the size of affected ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5605011/

Ultrasound-guided transcervical radiofrequency ablation for ...

The mean uterine volume reduction rate was 35.8% at 1 month, 40.8% at 6 months and 41.2% at 12 months post-ablation. Dysmenorrhoea and SSS statistically ...

4.

mdpi.com

mdpi.com/2077-0383/13/19/5828

Advances in Adenomyosis Treatment: High-Intensity ...

Results: Overall, the results showed that the above-mentioned ablation techniques are effective and safe in providing adenomyosis treatment.

5.

liebertpub.com

liebertpub.com/doi/full/10.1089/gyn.2023.0124?doi=10.1089/gyn.2023.0124

Radiofrequency Ablation in Focal Uterine Adenomyoma

Study Objective: To evaluate the long-term results of laparoscopic radiofrequency thermal ablation in the treatment of uterine symptomatic focal adenomyosis ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7810431/

Post-Market Safety of Laparoscopic Ultrasound-Guided ...

Minimally invasive gynecologic surgeons can learn laparoscopic intraabdominal ultrasound-guided radiofrequency ablation and perform it safely.

7.

tandfonline.com

tandfonline.com/doi/full/10.1080/02656736.2023.2217366

Transcervical radiofrequency ablation of focal adenomyosis

Transcervical fibroid ablation with Sonata System is a minimally invasive, incisionless, safe and effective method for the treatment of fibroids [Citation21].