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Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03516136
Enrollment
84
Registered
2018-05-04
Start date
2015-01-01
Completion date
2017-12-31
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.
Lead SponsorINDUSTRY

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

MeasureTime frameDescription
Safety- procedure and device related complication rateUp to 4 yearsPercentage of device and procedure related complications.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026