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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 2 years
Awards & highlights

Study 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 ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence of hernia recurrence
Secondary outcome measures
Pain and discomfort to patients using VAS

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
186 Previous Clinical Trials
226,614 Total Patients Enrolled
Ohio State UniversityOTHER
829 Previous Clinical Trials
505,673 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
Rebound Hernia Repair Device Mesh Trial
2009. "Rebound Hernia Repair Device Mesh Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00968773.
All > Hernia
~4 spots leftby Apr 2025
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