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Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.

NCT06620211 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2024-10-01

No results posted yet for this study

Summary

An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).

Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center. Data from consultation visits and surgery data will be collected and filled in the observation books.

The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up.

Conditions

  • Prolapse; Female

Interventions

PROCEDURE

promontofixation, prolapse cure

Patient who underwent surgery to place the Sacromesh® medical device (promontofixation) for a prolapse cure, between 2009 and 2018

Sponsors & Collaborators

  • Cousin Biotech

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2023-10-19
Completion
2023-10-19

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 NCT06620211 on ClinicalTrials.gov