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Can a new mesh implant fix pelvic organ prolapse better?

NCT ID NCT07066761

Disease control Sponsor: A.M.I. Agency for Medical Innovations GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests a new surgical mesh implant, called LatGYNious, used in a keyhole procedure to repair pelvic organ prolapse — a condition where pelvic organs drop from their normal position. The study will enroll about 85 women who need surgery for prolapse and will measure whether the implant successfully restores normal anatomy and improves symptoms and quality of life. The goal is to see if this device is a safe and effective option for long-term support.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a surgical mesh implant called LatGYNious used in laparoscopic lateral suspension
What this could lead to
If successful, this mesh implant could offer a safe and effective surgical option for women with pelvic organ prolapse, potentially improving anatomical correction and quality of life.
What could go wrong
This is a relatively small, non-randomized trial, so results may not apply to all patients. Mesh implants carry risks such as erosion, infection, or chronic pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus * Subject is candidate for a surgical treatment of pelvic organ prolapse * Subject is willing and able to cooperate with follow-up examinations * Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes. Exclusion Criteria: * Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment) * Active immunotherapy which may negatively affect the treatment with a surgical mesh * Active cancer of the vagina / cervix / rectum * . known or suspected hypersensitivity to Polypropylene * Pregnancy * participation in another study at the same time * Unable to understand study requirements or is unable to comply with follow-up schedule * Contraindicated according to the instruction for use of the device

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse prolapse of female genital organ Uterine Prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genital prolapse Laparoscopic surgery Pelvic organ prolapse (POP) Uterus prolapse

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BZK St. Johann in Tirol

    RECRUITING

    Sankt Johann in Tirol, Tyrol, 6380, Austria

  • Krankenhaus St. Joseph-Stift Bremen

    NOT_YET_RECRUITING

    Bremen, 28209, Germany

  • Medizincampus Bodensee - Klinik Tettnang

    NOT_YET_RECRUITING

    Tettnang, 88069, Germany

  • Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe

    NOT_YET_RECRUITING

    Brandenburg, 14770, Germany

  • Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe

    RECRUITING

    Wiener Neustadt, 2700, Austria

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