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

NCT07066761 | Recruiting

• 2 other identifiers: CI-52_001_LatGYNiousEUDAMED No: CIV-24-09-049116
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

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

Keywords

Laparoscopic lateral suspension (LLS)

Outcome Measures

Primary Outcomes (1)

• 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

  During follow-up until 6 and 12 months after surgery

Secondary Outcomes (3)

• Quality of Life (QoL)

  During follow-up until 6 and 12 months after surgery

• Subjective success

  During follow-up until 6 and 12 months after surgery

• Complications

  From operation during follow-up until 6 and 12 months after surgery.

Study Arms (1)

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

ACTIVE COMPARATOR

Device: Laparoscopic lateral suspension with surgical mesh (LatGYNious)

Interventions

Laparoscopic lateral suspension with surgical mesh (LatGYNious) DEVICE

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Also known as: surgical POP treatment, Pelvic organ prolapse

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• A.M.I. Agency for Medical Innovations GmbH: lead

Study Sites (5)

BZK St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, 6380, Austria

RECRUITING

LKH Feldkirch, Gynäkologie und Geburtshilfe

Feldkirch, 6800, Austria

RECRUITING

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

Brandenburg, 14770, Germany

NOT YET RECRUITING

Krankenhaus St. Joseph-Stift Bremen

Bremen, 28209, Germany

NOT YET RECRUITING

Medizincampus Bodensee - Klinik Tettnang

Tettnang, 88069, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Interventions

Surgical Mesh

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Tina Cadenbach-Blome, Dr. med.

  Medizincampus Bodensee - Klinik Tettnang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Blab

CONTACT

+43 5522 90505 4062; florian.blab@ami.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (3)