Ventral HerniasNCT02730936
Antimicrobial Hernia Repair Device
A study testing Antimicrobial Hernia Repair Device in people with Ventral Hernias and Incisional Hernias, run by Cook Group Incorporated.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventral Hernias, Incisional Hernias
- What is being tested?
- Antimicrobial Hernia Repair Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.
Who cannot join
- 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.
About this study
Official title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
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.
- Conditions
- Ventral Hernias, Incisional Hernias
- Being tested
- Antimicrobial Hernia Repair Device
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Hernia Repair DeviceDevice
hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Hernia Repair Device | Experimental | Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields. Receives: Device: Antimicrobial Hernia Repair Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Number of hernia recurrences
Hernia recurrences is the protrusion of abdominal tissue through a defect in the abdominal wall at the site of the hernia repaired during the index procedure.
Measured: 24 months
Frequency of procedural and post-operative adverse events
The adverse events will be bowel erosion, bowl obstruction, delayed wound infection, fever, fistula formation, graft contraction, hernia recurrence, ileus, need for revision/resurgery, pain, premature degradation, wound dehiscence, and other wound complications.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start12 Jan 2016 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Sponsor decision to discontinue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730936
- Sponsor's protocol ID
- 14-12
- Status last verified
- Feb 2017
- First submitted
- 30 Mar 2016
- Last updated
- 13 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
- ClinicalTrials.gov ID
- NCT02730936
- Acronym / sponsor ID
- 14-12
- Conditions
- Ventral Hernias, Incisional Hernias
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to discontinue the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2016 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Hernia Repair Device | Experimental | Device: Antimicrobial Hernia Repair DeviceAntimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial Hernia Repair Devicehernia repair | Device | Antimicrobial Hernia Repair Device |
Primary outcome
Number of patients that develop a surgical site infection
Time frame: 6 months
Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.
2 secondary outcomes
Number of hernia recurrences
Time frame: 24 months
Frequency of procedural and post-operative adverse events
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial Hernia Repair Device in people with Ventral Hernias and Incisional Hernias, run by Cook Group Incorporated.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that develop a surgical site infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.