Trials / Completed
CompletedNCT00393887
Inguinal Hernia Study Using Biodesign IHM
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Cook Group Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biodesign IHM | Biodesign IHM is placed to reinforce the hernia repair |
| DEVICE | Polypropylene mesh | Polypropylene mesh is used to reinforce the hernia repair. |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2006-10-30
- Last updated
- 2015-11-20
- Results posted
- 2015-08-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00393887. Inclusion in this directory is not an endorsement.