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Recruiting NCT07066761

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

No phase Interventional Pelvic Organ Prolapse (POP) Genital Prolapse Uterus Prolapse Laparoscopic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic lateral suspension with surgical mesh (LatGYNious).
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)

Overview

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.

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.

Interventions

  • Device Laparoscopic lateral suspension with surgical mesh (LatGYNious)
    Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Primary outcome measures

  • Objective success [Time frame: During follow-up until 6 and 12 months after surgery]
Secondary outcome measures (3)
  • Quality of Life (QoL) [Time frame: During follow-up until 6 and 12 months after surgery]
  • Subjective success [Time frame: During follow-up until 6 and 12 months after surgery]
  • Complications [Time frame: From operation during follow-up until 6 and 12 months after surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe — Brandenburg
  • Krankenhaus St. Joseph-Stift Bremen — Bremen
  • Medizincampus Bodensee - Klinik Tettnang — Tettnang
Austria · 2 centers
  • BZK St. Johann in Tirol — Sankt Johann in Tirol
  • Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe — Wiener Neustadt

Identifiers

NCT: NCT07066761 · CI-52_001_LatGYNious · EUDAMED No: CIV-24-09-049116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗