Pelvic Organ Prolapse (POP)NCT07066761
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
A study testing Laparoscopic lateral suspension with surgical mesh (LatGYNious) in people with Pelvic Organ Prolapse (POP) and Genital Prolapse, run by A.M.I. Agency for Medical Innovations GmbH at 5 sites in 2 countries.
Trial summary
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse
- What is being tested?
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Nov 2025to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
Brandenburg, 14770
Cormelia Dr. Müller, +49 3381411400, c.mueller@klinikum-brandenburg.de
- Not yet recruiting
Krankenhaus St. Joseph-Stift Bremen
Bremen, 28209
Kerstin Dr. Volkmer, +49 421/ 347- 1300, KVolkmerDr@sjs-bremen.de
- Not yet recruiting
Medizincampus Bodensee - Klinik Tettnang
Tettnang, 88069
Tina Dr. Cadenbach-Blome, +49 7542 531-6300, cadenbach-blome.tina@medizincampus.de
Austria2 sites, 2 recruiting
- Recruiting
BZK St. Johann in Tirol
Sankt Johann in Tirol, Tyrol, 6380
Christian Deetjen, Prim.Dr., +43 5352 606-500, deetjen@khsj.at
- Recruiting
Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe
Wiener Neustadt, 2700
Balázs Stenczer, OA Dr., +4326229004 ext. 0, balazs.stenczer@wienerneustadt.lknoe.at
About this study
Official title: Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
Read the detailed description
LatGYNious is a preformed mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh arms, which achieves a strong lateral fixation. The overlap area of the two mesh types is designed to combine the properties of both structures. In case of a uterus preserving approach, the posterior part of the mesh body is removed.
The aim of the present study is to generate clinical data to show the safety and performance of LatGYNious for the treatment of female pelvic organ prolapse.
- Being tested
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Keywords
- Laparoscopic lateral suspension (LLS)
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic lateral suspension with surgical mesh (LatGYNious)Device
Also called surgical POP treatment, Pelvic organ prolapse
Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy) | Active comparator | Not described Receives: Device: Laparoscopic lateral suspension with surgical mesh (LatGYNious) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective success
The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant.
Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively.
Objective cure is defined as:
- POP-Q values Ba, C and Bp < -1 (according to Barber et al.).
- Absence of pelvic floor prolapse/bulge symptoms based on questionnaire (P-QoL).
- No additional POP treatment necessary
Measured: During follow-up until 6 and 12 months after surgery
Secondary outcomes (3)
Quality of Life (QoL)
Quality of Life is determined by a validated questionnaire (P-QoL).
The P-QoL Total score ranging from 0 points (complete continence) to 24 points (complete incontinence). An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up).
Measured: During follow-up until 6 and 12 months after surgery
Subjective success
Subjective rating of pelvic floor function is determined by a validated questionnaire (Deutscher Beckenboden-Fragebogen / German Pelvic Floor Questionnaire (GPFQ)).
The GPFQ consist of 42 items, where each item has its scores. The scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21).
The final score were calculated as follows:
(achieved value of category/ max. value of category)*10 Therefore, the max. value is 10 for each category and the final score is maximum 40.
An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up).
Measured: During follow-up until 6 and 12 months after surgery
Complications
All adverse events will be reported.
Serious device- and procedure-related adverse events will be summarized separately.
Measured: From operation during follow-up until 6 and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Cadenbach-Blome, Dr. med., Principal investigator, Medizincampus Bodensee - Klinik Tettnang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066761
- Sponsor's protocol ID
- CI-52_001_LatGYNious
- Other IDs
- EUDAMED No: CIV-24-09-049116
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No