Antimicrobial Hernia Repair Device

Cook Group

Status: Withdrawn

Conditions: Ventral Hernias; Incisional Hernias

Treatments: Device: Antimicrobial Hernia Repair Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02730936

14-12

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Antimicrobial Hernia Repair Device

Experimental group

Description:

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

Treatment:

Device: Antimicrobial Hernia Repair Device