Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Ventral Hernia Clinical Trial

Official title:

A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866814
• Other study ID #: DVL-HE004
• Status: Completed
• Phase: N/A
• First received: March 20, 2009
• Last updated: October 10, 2012
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	RUSH Univeristy Medical Center	Chicago	Illinois
United States	Gaston Memorial Hospital	Gastonia	North Carolina
United States	Sacred Heart Health System, Inc.	Pensacola	Florida
United States	Associated Surgical Group	Peoria	Illinois
United States	Sutter Medical Group GNS	Sacramento	California
United States	Novant Clinical Research Institute	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	FGK Clinical Research GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.	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.	1 year post surgery	No
Secondary	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.	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.	From the time of surgery to hospital discharge, an average of 1-2 days	Yes
Secondary	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.	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.	Hospital discharge through 21 days post surgery	Yes
Secondary	Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.	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.	22 days post surgery through 1 year post surgery	Yes
Secondary	Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey	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.	Baseline and post-surgery at week 2, month 6 and month 12	No
Secondary	Procedure Time	Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.	Day of surgery	No