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Mesh Device

The Rebound hernia repair device with no fixation for Inguinal Hernia

Phase 4
Waitlist Available
Led By John S Roth, MD
Research Sponsored by Minnesota Medical Development, 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 up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference. The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.

Eligible Conditions
  • Inguinal Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: The Rebound hernia repair device with no fixationExperimental Treatment1 Intervention
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
Group II: Standard Hernia Mesh using fixationActive Control1 Intervention
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.

Find a Location

Who is running the clinical trial?

Minnesota Medical Development, Inc.Lead Sponsor
University of KentuckyOTHER
190 Previous Clinical Trials
220,675 Total Patients Enrolled
Ohio State UniversityOTHER
866 Previous Clinical Trials
655,087 Total Patients Enrolled
~4 spots leftby Nov 2025
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