Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Completed
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT03516136
- Lead Sponsor
- Allium, Ltd.
- Brief Summary
A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
Inclusion Criteria
- Female subjects >18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP
Exclusion Criteria
- Patients without follow-up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety- procedure and device related complication rate Up to 4 years Percentage of device and procedure related complications.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie apical support in pelvic organ prolapse treatment with EndoFast Reliant SCP?
How does the EndoFast Reliant SCP compare to native tissue repair in vaginal wall reinforcement outcomes?
Are there specific biomarkers that predict successful vaginal wall reinforcement using synthetic mesh implants?
What adverse event profiles are associated with synthetic mesh implants for pelvic organ prolapse management?
What are the current alternatives to EndoFast Reliant SCP in vaginal wall reinforcement therapies?