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.
NCT ID: NCT06620211
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
290 participants
OBSERVATIONAL
2020-04-23
2023-10-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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promontofixation, prolapse cure
Patient who underwent surgery to place the Sacromesh® medical device (promontofixation) for a prolapse cure, between 2009 and 2018
Eligibility Criteria
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Inclusion Criteria
• Patient who has read the information note and has not formulated an -opposition.
• Adult patient with full mental capacity/capability
Exclusion Criteria
• Patient hospitalized at time of inclusion
• Patient with an adjacent pathology that may strongly interfere with her quality of life and VAS score.
* Patients with mental psychological pathology
18 Years
FEMALE
No
Sponsors
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Cousin Biotech
INDUSTRY
Responsible Party
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Locations
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Cousin Biotech
Wervicq-Sud, , France
Countries
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Other Identifiers
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RC-P-T3-33
Identifier Type: -
Identifier Source: org_study_id
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