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A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Clinical Trial Summary

The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

Clinical Trial Description

Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01111409
Study type Interventional
Source Ethicon, Inc.
Contact
Status Completed
Phase N/A
Start date March 2010
Completion date June 2011
View Details
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