At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
Biodesign IHM +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
In Brief
A clinical study evaluating Biodesign IHM and Polypropylene mesh for Inguinal Hernia. Completed, enrolled 100 participants across 1 site.
Detailed Summary
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInguinal Hernia
CountriesUnited States
CollaboratorsCook Biotech Incorporated, MED Institute, Incorporated
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartMar 2007
Primary CompletionJun 2014
TodayJul 2026
First PostedOct 30, 2006
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.7 years ago
Interventions
Biodesign IHMdevice
Biodesign IHM is placed to reinforce the hernia repair
Polypropylene meshdevice
Polypropylene mesh is used to reinforce the hernia repair.