RecruitingOBSERVATIONAL

Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis

This study is investigating the long-term effects of a treatment called High-Intensity Focused Ultrasound (HIFU) for women who have bowel endometriosis. Endometriosis is a condition where tissue similar to the lining of the womb grows elsewhere in the body, causing pain and other problems. The researchers want to understand how HIFU affects symptoms over time for patients who have already received this treatment in previous studies. These patients will be asked to complete an online questionnaire and have a follow-up phone call to share their experiences. The aim is to gather information that can help doctors better understand the lasting benefits of HIFU for this specific condition.

At a glance

Status

Recruiting

Sponsor

EDAP TMS S.A.

Enrolment target

140

Start

10 Oct 2021

Estimated completion

30 Sep 2029

Endometriosis

What is this study about?

This study focuses on a condition called endometriosis, specifically when it affects the bowel (also known as rectal endometriosis). Endometriosis can cause a lot of pain and discomfort, and doctors are always looking for effective treatments. One treatment option is called High-Intensity Focused Ultrasound, or HIFU, which uses special sound waves to treat the affected areas.

Researchers want to understand how well HIFU works in the long run for women who have had this treatment for their bowel endometriosis. They are particularly interested in checking in with patients who took part in a few earlier studies (named HIFU/F/13.12, ENDO HIFU R1, and ENDO HIFU R2). By looking at how these patients are doing now, the study hopes to find out if HIFU provides lasting relief from symptoms.

This information is important because it helps doctors and patients make better decisions about treatment for bowel endometriosis. Knowing the long-term effects of HIFU can help medical professionals understand if it's a good option for managing the condition and improving quality of life for patients over many years.

Key takeaways

This study evaluates long-term effects of HIFU for bowel endometriosis.
It's for women who previously received HIFU in specific earlier studies.
Participation involves an online questionnaire and a phone call.
No new medical treatments or hospital visits are required.
Your input helps improve understanding of HIFU's lasting benefits.

Who may be eligible?

This study is for women aged 18 or over. To take part, you must have previously received HIFU treatment for endometriosis in your bowel as part of one of these earlier studies: HIFU/F/13.12, ENDO HIFU R1, or ENDO HIFU R2.

It's important that you have access to the internet, as you'll need to complete questionnaires online. You also need to be happy to formally agree to take part in this follow-up study.

Unfortunately, you cannot take part if you are currently under guardianship (someone else legally manages your affairs) or if you are in a situation where your freedom is restricted, such as being in prison.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you previously have HIFU treatment for bowel endometriosis in studies HIFU/F/13.12, ENDO HIFU R1, or ENDO HIFU R2?
Do you have access to the internet to complete online questionnaires?
Are you able to provide consent to participate in the study?
Are you not currently under guardianship or in detention?

Answer every question to see your result.

What does participation involve?

If you meet the requirements and agree to take part, your participation will involve two main steps. First, you will be asked to complete an electronic questionnaire. This will likely cover questions about your symptoms and how you've been feeling since your HIFU treatment.

After completing the questionnaire, you will receive a telephone call from the study team. This call will be to check in with you, gather more information about your health and treatment experience, and answer any questions you might have. There are no medications involved in this follow-up study, and you won't need to attend any clinic visits. The total duration of your involvement will be quite short, mainly revolving around completing the questionnaire and the phone call.

Potential risks and benefits

The potential benefits of taking part in this study are indirect; your experience will help researchers understand the long-term effectiveness of HIFU for bowel endometriosis, which could improve care for other women in the future. As you have already received the treatment, this study primarily involves sharing your experience, so there are no new medical risks associated with the HIFU treatment itself. The main risk is the time commitment for the questionnaire and phone call, and some might find discussing their health history emotionally taxing. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

Hopital de la Croix Rousse
Verified postcode
Lyon, France· Recruiting

Common questions

What is HIFU?

HIFU stands for High-Intensity Focused Ultrasound. It's a medical treatment that uses specially focused sound waves to treat affected areas, like endometriosis.

Why are you doing this study?

We want to understand how well HIFU treatment works in the long term for women with endometriosis in their bowel, so we can help future patients.

Do I need to visit a hospital?

No, you won't need to visit a hospital. This study only involves filling out an online questionnaire and having a phone call.

Who can take part?

This study is for women aged 18 or over who previously had HIFU treatment for bowel endometriosis in specific earlier studies and have internet access.

What if I change my mind?

You can decide to withdraw from the study at any time, and this will not affect your medical care.

How to find out more

Djamila BENNAT

affaires-cliniques@edap-tms.com +33 472 153 125 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.