Rebound Hernia Repair Device Mesh Trial

NCT00968773 | Unknown Phase 4 DMC

• 1 other identifier: Rebound HRD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

inguinal hernia; mesh; hernia repair device

Outcome Measures

Primary Outcomes (1)

• Presence of hernia recurrence

  2 years

Secondary Outcomes (1)

• Pain and discomfort to patients using VAS

  2 years

Study Arms (2)

The Rebound hernia repair device with no fixation

EXPERIMENTAL

Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.

Device: Rebound HRD

Standard Hernia Mesh using fixation

ACTIVE COMPARATOR

Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.

Device: Standard hernia mesh (VitaMesh)

Interventions

Rebound HRD DEVICE

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

The Rebound hernia repair device with no fixation

Standard hernia mesh (VitaMesh) DEVICE

Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Also known as: VitaMesh

Standard Hernia Mesh using fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minnesota Medical Development, Inc.: lead
• University of Kentucky: collaborator
• Ohio State University: collaborator

Study Sites (2)

University of Kentucky Dept. Of Surgery

Lexington, Kentucky, 40536-0293, United States

Location

The Ohio State Medical Center, Dept. of Surgery

Columbus, Ohio, 43210-1228, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John S Roth, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Jeffrey W Hazey, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 31, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 15, 2016

Record last verified: 2009-09

Locations

US (2)