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Surgical Mesh

SERI® Surgical Scaffold for Ventral Hernia Repair

N/A
Waitlist Available
Research Sponsored by Sofregen Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months postoperatively
Awards & highlights

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.

Eligible Conditions
  • Ventral Hernia Repair

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Hernia Recurrence

Trial Design

1Treatment groups
Experimental Treatment
Group I: SERI® Surgical ScaffoldExperimental Treatment1 Intervention
It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silk surgical mesh
2013
N/A
~20

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Who is running the clinical trial?

Sofregen Medical, Inc.Lead Sponsor
8 Previous Clinical Trials
361 Total Patients Enrolled
Medical DirectorStudy DirectorAllergan Medical
2,846 Previous Clinical Trials
8,080,695 Total Patients Enrolled
~0 spots leftby Sep 2025
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