Phase
Condition
Hernia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years of age or greater
Have a BMI <40
Have a hernia of at least 200 cm^2
Have no contraindications to test material(s)
Have a life expectancy greater than 1 year in the opinion of the Investigator
Able to provide informed consent
Able and willing to return for scheduled study visits over 1 year post-operatively (following research related surgery)
Exclusion
Exclusion Criteria:
< 18 years of age
Subject is determined to have an America Society of Anesthesiologists' (ASA) physicalclass of 4, 5, or 6.
Have a BMI > 40
Have a hernia < 2002 cm
Have abdominal loss of domain such that the operation would be impractical or wouldadversely affect respiratory or cardiovascular function to an unacceptable degree inthe opinion of the Investigator
Inability to close the fascia primarily without abdominal wall mobilization orcomponent separation
Participation in an investigational drug or device study within the past 6 weeks priorto enrollment into this trial
Have active necrotizing fasciitis or any other known active local or systemicinfection
Have a known collagen metabolism disorder or any medical condition that couldinterfere with normal tissue healing process as determined by the Investigator
Have a known active malignancy present and/or had chemotherapy 12 weeks prior toscreening or planned chemotherapy within 12 weeks of enrollment with the exception ofBCC or SCC
Have known moderate to severe cirrhosis which in the opinion of the Investigator wouldimpact the outcome of this trial
Have a life expectancy less than 1 year.
Be unable to participate in the informed consent process
Be unable or unwilling to return for scheduled study visits over the 1 yearpost-operative assessment period
Subject's ventral hernia is related to an organ transplant surgery
Received high dose steroids (≥100mg of prednisone) within the past 6 weeks
Tobacco use within the past 6 weeks or positive serum cotinine test at time ofadmission
Uncontrolled diabetes (i.e. known HbA1C value > 7%)
History of drug addiction (recreational drugs, prescription drugs or alcohol) that inthe Investigator's opinion may interfere with protocol assessments and/or thesubject's ability to complete the required follow up
Pregnancy and/or breastfeeding
Enterocutaneous fistula
Undergoing concomitant panniculectomy
Ventral hernia repairs involving actively infected mesh removal
Inability to obtain primary fascial closure (Intra-operatively)
Study Design
Study Description
Connect with a study center
Pines Surgical
Pembroke Pines, Florida 33028
United StatesSite Not Available
Washington University in St Louis, Barnes Jewish Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University in St Louis, Barnes Jewish Hospital
St Louis, Missouri 63110
United StatesSite Not Available
CentraState Medical Center
Freehold, New Jersey 07728
United StatesSite Not Available

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