SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Ventral Hernia Repair Clinical Trial

Official title:
A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Status Terminated

Clinical Trial Summary

Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.

Clinical Trial Description

Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01981044
Study type	Interventional
Source	Sofregen Medical, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	September 25, 2013
Completion date	February 24, 2016

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See also
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Recruiting	`NCT04132986` - Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair