Study of Surgical Mesh for Inguinal Hernia Repair | NCT00924755

Studies
Study of Surgical Mesh for Inguinal Hernia Repair

NCT00924755

Sponsor

Biomerix

Status

Unknown status

Last Update Posted

Oct 4, 2010Estimated

Enrollment

25Estimated

Phase

Phase 4

Conditions

Hernia, Inguinal

Interventions

Biomerix Revive™ (surgical mesh for inguinal hernia repair)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jun 18, 2009

First Posted Date

Jun 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2010

Last Update Posted Date

Oct 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
Biomerix Revive™ (surgical mesh for inguinal hernia repair)	Device	Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.		Revive

Measure	Description	Time Frame
Technical success with no complications through 6 weeks.		6 weeks

Measure	Description	Time Frame
Hernia recurrence		1 year
Pain and functional status		10 day, 6 weeks, 6 months 1 year
Incidence of complications

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male ≥19 years old
symptomatic and palpable inguinal hernia
candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
will comply with required follow-up study visits
willing and able to provide written informed consent

Exclusion Criteria:

BMI ≥35
life expectancy of <3 years
strangulated hernia
urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
active abdominal surgical condition such as bowel obstruction or perforation
local or systemic infection or peritonitis
known disease that impairs wound healing
anti-platelet therapy (other than aspirin) for >7 days preceding the surgical procedure
previous ipsilateral groin incision
receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
advanced cirrhosis with Child-Turcott Class of C or higher
severe COPD requiring home oxygen
diagnosed with chronic pain syndrome or is undergoing treatment for pain management
candidate for another major surgical procedure with the inguinal hernia repair
enrolled in another investigational study that may confound the results of this study
known drug abuser
on anti-psychotic medications
Worker's Compensation case

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University		Omaha	Nebraska	68178	United States
Michael E. DeBakey Veterans Affairs Medical Center

Type	Date	Date Unknown
Release	Mar 20, 2017
Reset	Apr 28, 2017

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013523	Surgical Equipment
D004864	Equipment and Supplies