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New mesh implant aims to fix pelvic organ prolapse safely

NCT ID NCT07497321

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a new mesh implant called ProGYNious for repairing pelvic organ prolapse in 100 women. The goal is to see how well it works and if it is safe. Participants will be followed for complications and quality of life after surgery.

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 100 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 to 80 years

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: * Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation * Symptomatic pelvic organ prolapse with POP-Q \>= 2 * Age \>18 years and ≤ 80years * 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 Exclusion Criteria: * previous or concurrent cancer which may affect the successful treament with laparoscopic mesh * known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene) * known severe osteoporosis * pregnancy, suspected pregnancy and breastfeeding * bleeding of unknown cause in the genital area * previously irradiated patients in the pelvic area * drug or medication abuse, medical, psychological or social circumstances that could affect the patient's participation in the study or the evaluation of the study results * Any previous interventions with surgical mesh for pelvic organ prolapse and/or urinary incontinence * Unable to understand study requirements or is unable to comply with follow-up schedule * Contraindicated according to the instruction for use of the device * patients with an increased risk of infection or impaired wound healing (e.g. Diabetes mellitus with HbA1c \>10, systemic autoimmune diseases, etc.) * concomitant Sling/TVT procedure * life expectancy lower than follow-up period (e.g. ASA 4) * non-symptomatic pelvic organ prolapse * chronic pain syndrome * chronic respiratory disease (e.g. COPD, chronic cough)

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Conditions

The condition(s) this trial relates to.

breast implant illness pelvic organ prolapse

As listed by the trial registrant

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

Gynecologic laparoscopic surgery Implant Laparoscopic surgery Pelvic floor Pelvic floor prolapse Pelvic organ prolapse (POP) Sacrocolpopexy Synthetic mesh

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

  • Kardinal Schwarzenberg Klinikum

    Schwarzach im Pongau, State of Salzburg, 5620, Austria

  • Klinik Agatharied, Gynäkologie & Geburtshilfe

    Hausham, Bavaria, 83734, Germany

  • Universitätsklinikum Erlangen, Frauenklinik

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe

    Wiener Neustadt, Lower Austria, 2700, Austria

  • Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe

    Frankfurt am Main, Hesse, 60596, Germany

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