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

NCT01981044 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-08-26

Study results available
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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.

Conditions

  • Ventral Hernia Repair

Interventions

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

Sponsors & Collaborators

  • Sofregen Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-25
Primary Completion
2015-09-25
Completion
2016-02-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981044 on ClinicalTrials.gov