Rebound Hernia Repair Device Mesh Trial

M

Minnesota Medical Development, Inc.

Status and phase

Unknown
Phase 4

Conditions

Inguinal Hernia

Treatments

Device: Standard hernia mesh (VitaMesh)
Device: Rebound HRD

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00968773
Rebound HRD

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 to 80 years of age Unilateral or bilateral inguinal hernia (moderate in size), primary in nature

Exclusion criteria

Unable to provide informed consent Assessed as ASA 3 or 4 Renal failure;creatinine greater than 2.0mg percent Ascites as determined by clinical suspicion/ultrasound confirmation Known pregnancy Femoral hernias Diabetes requiring injectable insulin Prior lower abdominal surgery through lower midline or Pfannenstiel incision TAPP approach Requiring anticoagulants during surgery Participation in another study involving another device or drug Emergent procedures for hernia incarceration and strangulation Recurrent inguinal hernias

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

The Rebound hernia repair device with no fixation
Experimental group
Description:
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
Treatment:
Device: Rebound HRD
Standard Hernia Mesh using fixation
Active Comparator group
Description:
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.
Treatment:
Device: Standard hernia mesh (VitaMesh)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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