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Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems

Pelvic Organ Prolapse Clinical Trial

Official title:
Calistar A vs. Calistar S - Cohort Retrospective Analysis

Clinical Trial Summary

The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).

Clinical Trial Description

The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03715803
Study type Observational
Source University of Buenos Aires
Contact
Status Completed
Phase
Start date October 25, 2018
Completion date December 30, 2019
View Details
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