Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

C. R. Bard119 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

119

Conditions

Ventral Hernia

Interventions

Bard Ventrio Hernia PatchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Sutter Medical Group GNS

Sacramento, California, United States

Sacred Heart Health System, Inc.

Pensacola, Florida, United States

RUSH Univeristy Medical Center

Chicago, Illinois, United States

Associated Surgical Group

Peoria, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year post surgery

Secondary Outcomes

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.

Time frame: From the time of surgery to hospital discharge, an average of 1-2 days

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.

Time frame: Hospital discharge through 21 days post surgery

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.

Time frame: 22 days post surgery through 1 year post surgery

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.

Data from ClinicalTrials.gov

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