Antimicrobial Hernia Repair Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2020-07-31

Brief Summary

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This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

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Detailed Description

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Conditions

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Ventral Hernias Incisional Hernias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antimicrobial Hernia Repair Device

Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.

Group Type EXPERIMENTAL

Antimicrobial Hernia Repair Device

Intervention Type DEVICE

hernia repair

Interventions

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Antimicrobial Hernia Repair Device

hernia repair

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria

* Less than 21 years old
* Unwilling or unable to sign and date the informed consent
* Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
* Unable or unwilling to comply with follow-up schedule
* Simultaneously participating in another investigational drug or device study.
* Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No