Rebound Hernia Repair Device Mesh Trial

Rebound Hernia Repair Device Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968773

Enrollment

Registered

2009-08-31

Start date

2009-09-30

Completion date

2013-09-30

Last updated

2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

inguinal hernia, mesh, hernia repair device

Brief 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.

Interventions

DEVICERebound HRD

Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation

DEVICEStandard hernia mesh (VitaMesh)

Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Presence of hernia recurrence	2 years

Secondary

Measure	Time frame
Pain and discomfort to patients using VAS	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026