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Biologic Mesh

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington for Hiatal Hernia

Phase 4
Waitlist Available
Research Sponsored by Stony Brook University
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 quality of life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
Awards & highlights

Study Summary

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Eligible Conditions
  • Hiatal Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quality of life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and quality of life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess for reappearance of hiatal hernia and reflux
Secondary outcome measures
Quality of Life questionnaire

Trial Design

2Treatment groups
Active Control
Group I: Biodesign™ Surgisis® Graft, Cook Medical, BloomingtonActive Control2 Interventions
Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia
Group II: Parietex™ Composite Hiatal Mesh, North Haven, CTActive Control2 Interventions
Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
214 Previous Clinical Trials
39,515 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
2014. "Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02242526.
All > Hernia
~29 spots leftby Apr 2025
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