Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00866814|
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : May 21, 2012
Last Update Posted : October 12, 2012
|Condition or disease||Intervention/treatment|
|Ventral Hernia||Device: Bard Ventrio Hernia Patch|
|Study Type :||Observational|
|Actual Enrollment :||119 participants|
|Official Title:||A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
Device: Bard Ventrio Hernia Patch
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
- The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. [ Time Frame: 1 year post surgery ]A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.
- 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. [ Time Frame: From the time of surgery to hospital discharge, an average of 1-2 days ]In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
- 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. [ Time Frame: Hospital discharge through 21 days post surgery ]In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
- Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. [ Time Frame: 22 days post surgery through 1 year post surgery ]In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
- Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey [ Time Frame: Baseline and post-surgery at week 2, month 6 and month 12 ]Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure.
- Procedure Time [ Time Frame: Day of surgery ]Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866814
|United States, California|
|Sutter Medical Group GNS|
|Sacramento, California, United States|
|United States, Florida|
|Sacred Heart Health System, Inc.|
|Pensacola, Florida, United States, 32504|
|United States, Illinois|
|RUSH Univeristy Medical Center|
|Chicago, Illinois, United States|
|Associated Surgical Group|
|Peoria, Illinois, United States|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28204|
|Gaston Memorial Hospital|
|Gastonia, North Carolina, United States, 28054|
|Novant Clinical Research Institute|
|Winston-Salem, North Carolina, United States, 27103|
|Principal Investigator:||David Iannitti, MD, FACS||Carolinas Medical Center|