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Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

NCT02011373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-19

No results posted yet for this study

Summary

Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.

Conditions

  • Medial and/or Anterior Genital Prolapse

Interventions

PROCEDURE

fixation technique using a sterile synthetic liquid tissue glue: IFABOND™

Sponsors & Collaborators

  • Vitalitec

    collaborator UNKNOWN

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Gery Lamblin, MD · Gynaecology Department, Hôpital Femme Mère Enfant, Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-06
Primary Completion
2018-10-30
Completion
2018-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011373 on ClinicalTrials.gov