RecruitingNAINTERVENTIONAL

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)

This study is investigating a new surgical mesh implant, called LatGYNious, for women who experience pelvic organ prolapse. This is a common condition where organs like the bladder or womb drop down, causing discomfort. The study aims to see if using LatGYNious during 'keyhole' (laparoscopic) surgery effectively supports these organs and improves symptoms. Researchers want to make sure the mesh is both safe and works as intended to significantly improve the prolapse. If you have symptomatic pelvic organ prolapse and are considering surgery, this trial is looking at whether this specific new mesh can offer a better solution for you. We are not making any recommendations, just explaining what this particular study is about.

At a glance

Status

Recruiting

Phase

Sponsor

A.M.I. Agency for Medical Innovations GmbH

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jul 2027

Pelvic Organ Prolapse (POP)Genital Prolapse Uterus Prolapse Laparoscopic Surgery

What is this study about?

Many women experience something called pelvic organ prolapse, which can be uncomfortable. This is when organs like your bladder, womb (uterus), or bowel can slip out of their normal position and drop down, sometimes creating a bulge. This trial is looking into a new way to help fix this using a special type of surgical mesh, called LatGYNious. The mesh is designed to act like a hammock, giving support to these organs and helping them stay in place.

The LatGYNious mesh is quite clever. It's made from two different types of strong, lightweight material, carefully designed to be flexible where needed and stronger in other areas for firm support. This mesh would be put into place using a 'keyhole' surgery technique, which often means smaller cuts and a quicker recovery than traditional open surgery. The main goal of this study is to check if this new mesh is safe to use and if it does a good job of improving prolapse symptoms and supporting the pelvic organs.

Researchers want to gather clear information to show that LatGYNious helps women with pelvic organ prolapse feel better and have a good outcome after surgery. They will be carefully watching how the mesh performs and if patients have any problems. This kind of research is important because it helps doctors find the best and safest ways to treat common health conditions.

Key takeaways

Tests a new mesh (LatGYNious) for pelvic organ prolapse.
Uses 'keyhole' surgery to support organs.
Aims to improve symptoms and ensure safety.
Involves follow-up appointments after surgery.
Suitable for women aged 18+ who need prolapse surgery.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women aged 18 or older who have symptoms of pelvic organ prolapse, which means one or more of their pelvic organs (like the womb or bladder) have dropped. You should be someone who would normally be considered for surgery to fix your prolapse.

However, there are reasons why you might not be able to join. For example, if you've already had surgery for pelvic organ prolapse using a mesh implant, you won't be able to take part. Also, if you're pregnant, have certain types of cancer, are allergic to plastic (polypropylene), or are taking certain strong medications (like some for immunotherapy), the study wouldn't be suitable for you.

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.

Do you have symptomatic pelvic organ prolapse (where an organ has dropped and causes symptoms)?
Are you able to attend follow-up appointments as required by the study?
Have you *not* had previous surgery for pelvic prolapse using a mesh implant?
Are you *not* pregnant or allergic to polypropylene (the material the mesh is made from)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a discussion with your healthcare team to understand everything involved and sign a consent form. You will then undergo the 'keyhole' surgery where the LatGYNious mesh will be implanted to support your pelvic organs. After your surgery, you will need to attend follow-up appointments. These appointments are important for the medical team to check your recovery, make sure the mesh is working well, and see if your prolapse symptoms have improved. They will also look for any side effects. You'll need to be willing and able to come to these appointments as scheduled so the team can gather all the necessary information. The exact number and timing of appointments will be explained to you in detail.

Potential risks and benefits

Participating in this study might offer you the potential benefit of having a new type of mesh to treat your pelvic organ prolapse, which could lead to better support and fewer symptoms. However, like all surgeries, there are potential risks, including those related to the surgery itself, and potential side effects from the mesh. These will be discussed fully with you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

BZK St. Johann in Tirol
Verified postcode
Sankt Johann in Tirol, Austria· Recruiting
LKH Feldkirch, Gynäkologie und Geburtshilfe
Verified postcode
Feldkirch, Austria· Recruiting
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
Verified postcode
Brandenburg, Germany· Not yet recruiting
Krankenhaus St. Joseph-Stift Bremen
Verified postcode
Bremen, Germany· Not yet recruiting
Medizincampus Bodensee - Klinik Tettnang
Verified postcode
Tettnang, Germany· Not yet recruiting

Common questions

What is pelvic organ prolapse?

It's when organs like your bladder or womb drop down, causing discomfort or a feeling of a bulge.

What is LatGYNious?

It's a new type of surgical mesh designed to support your pelvic organs during 'keyhole' surgery.

What kind of surgery is involved?

The mesh is implanted using 'keyhole' (laparoscopic) surgery, which typically means smaller cuts.

Who can't join this study?

If you've had previous prolapse mesh surgery, are pregnant, or have an allergy to polypropylene, you can't join.

Will I have to pay to be in the study?

No, participating in a clinical study for a medical device generally does not involve personal costs.

How to find out more

Florian Blab

florian.blab@ami.at +43 5522 90505 4062 Official trial record

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