Pelvic Organ Prolapse
Conditions
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.
Interventions
DEVICEEndoFast Reliant SCP
POP repair procedure with the EndoFast Reliant SCP system
Sponsors
Allium, Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Female subjects \>18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP
Exclusion criteria
1\. Patients without follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety- procedure and device related complication rate | Up to 4 years | Percentage of device and procedure related complications. |
Outcome results
None listed