Clinical trial NCT00866814: Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
Official title: A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: hernia
open
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2009-03-23
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.

Brief summary: This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age ≥ 18
2. Be able to undergo study procedures
3. Have signed an Informed Consent form (ICF)
4. Be diagnosed with a ventral hernia requiring an open surgery for repair.

Exclusion Criteria:

1. Patient is participating in another device or drug study.
2. Patient exhibits clinical symptoms indicating infected hernia site.
3. Patient currently has a clean contaminated or contaminated site.
4. Patient has a life expectancy less than 2 years at the time of enrollment.
5. Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.

Primary outcomes:
measure: The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
timeFrame: 1 year post surgery
Secondary outcomes:
measure: Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.
timeFrame: From the time of surgery to hospital discharge, an average of 1-2 days
measure: Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.
timeFrame: Hospital discharge through 21 days post surgery
measure: Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
timeFrame: 22 days post surgery through 1 year post surgery
measure: Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
timeFrame: Baseline and post-surgery at week 2, month 6 and month 12
measure: Procedure Time
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Medical Group GNS
state: California
city: Pensacola
country: United States
facility: Sacred Heart Health System, Inc.
state: Florida
city: Chicago
country: United States
facility: RUSH Univeristy Medical Center
state: Illinois
city: Peoria
country: United States
facility: Associated Surgical Group
state: Illinois
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: David Iannitti, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: