NCT02730936

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

March 30, 2016

Last Update Submit

February 10, 2017

Conditions

Ventral HerniasIncisional Hernias

Outcome Measures

Primary Outcomes (1)

  • Number of patients that develop a surgical site infection

    Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.

    6 months

Secondary Outcomes (2)

  • Number of hernia recurrences

    24 months

  • Frequency of procedural and post-operative adverse events

    24 months

Study Arms (1)

Antimicrobial Hernia Repair Device

EXPERIMENTAL

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

Device: Antimicrobial Hernia Repair Device

Interventions

Antimicrobial Hernia Repair DeviceDEVICE

hernia repair

Antimicrobial Hernia Repair Device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 7, 2016

Study Start

January 12, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2020

Last Updated

February 13, 2017

Record last verified: 2017-02