NCT01981044

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sofregen Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventral Hernia Repair

Interventions

Type	Name	Description
DEVICE	Silk surgical mesh	A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair

Timeline

• Start date: 2013-09-25
• Primary completion: 2015-09-25
• Completion: 2016-02-24
• First posted: 2013-11-11
• Last updated: 2022-08-26
• Results posted: 2022-08-26

Locations

1 site across 1 country: United States