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The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.
This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.
This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign Hernia Graft | Device | The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe. |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence | Hernia recurrence through 1-year follow-up | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Device-, Procedure-, and Hernia-related Adverse Event Rates | Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates) | 2-year |
| Hernia Recurrence Rate Through 2-year Follow-up |
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Inclusion Criteria:
1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft
Exclusion Criteria:
Known sensitivity to porcine material
For the study, the following patients will also be excluded:
Age < 18 years
Unable or unwilling to provide informed consent
Life expectancy of less than one year from the date of the index procedure
Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.
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Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States | ||
| St. Paul's Hospital |
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21 patients that were consented failed the screen.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All consented patients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
| ||||||||||||||||
| 6- month follow-up completed |
| ||||||||||||||||
| 1 year follow-up completed |
| ||||||||||||||||
| 2-year follow-up completed |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants That Completed 1 Month Follow-up | All participants that completed at least the 1 month follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hernia Recurrence | Hernia recurrence through 1-year follow-up | Posted | Count of Participants | Participants | 1-year |
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Through the 2-year follow-up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants that had follow-ups | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rae Ritchie | Cook Biotech Incorporated (d/b/a Evergen) | 765-497-3355 | rritchie@evergenbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2019 | Feb 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up
| 2-year |
| Operative Times | What was the operation time for the ventral hernia repair for patients who had a follow-up at least 1 month after procedure. | During operation |
| Hospital Stays for Serious Adverse Events | Number of patients with serious adverse events that required a hospital stay | 2-year |
| Hospitalization Times for Related Serious Adverse Events (SAEs) | Hospitalization times for patients with related Serious Adverse Events (SAEs). For patients who were followed up to 2 years after procedure. | From date of hospitalization for SAE. Patients were followed up to 2 years. |
| Patient-reported Quality of Life: Yes/No | Patient-reported quality of life assessed by completion of a questionaire | 2-year |
| Patient Reported Quality of Life-Pain Questions | Patient reported quality of life related to pain | 2-year follow-up |
| Patient Reported Quality of Life-abdominal Wall | patient reported quality of life related to abdominal wall | 2-year follow-up |
| Vancouver |
| British Columbia |
| V6Z 1Y6 |
| Canada |
| Queen Elizabeth II Hospital | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Number of patients with hernia | Number of patients with ventral hernia | Count of Participants | Participants |
|
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| Secondary | Device-, Procedure-, and Hernia-related Adverse Event Rates | Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates) | Posted | Number | events | 2-year |
|
|
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| Secondary | Hernia Recurrence Rate Through 2-year Follow-up | Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up | Posted | Number | Hernia Recurrence | 2-year |
|
|
|
| Secondary | Operative Times | What was the operation time for the ventral hernia repair for patients who had a follow-up at least 1 month after procedure. | Posted | Count of Participants | Participants | During operation |
|
|
|
| Secondary | Hospital Stays for Serious Adverse Events | Number of patients with serious adverse events that required a hospital stay | Posted | Count of Participants | Participants | 2-year |
|
|
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| Secondary | Hospitalization Times for Related Serious Adverse Events (SAEs) | Hospitalization times for patients with related Serious Adverse Events (SAEs). For patients who were followed up to 2 years after procedure. | Posted | Mean | Standard Deviation | days | From date of hospitalization for SAE. Patients were followed up to 2 years. |
|
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| Secondary | Patient-reported Quality of Life: Yes/No | Patient-reported quality of life assessed by completion of a questionaire | Posted | Count of Participants | Participants | 2-year |
|
|
|
| Secondary | Patient Reported Quality of Life-Pain Questions | Patient reported quality of life related to pain | Posted | Count of Participants | Participants | 2-year follow-up |
|
|
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| Secondary | Patient Reported Quality of Life-abdominal Wall | patient reported quality of life related to abdominal wall | Posted | Count of Participants | Participants | 2-year follow-up |
|
|
|
| 47 |
| 10 |
| 47 |
| 14 |
| 47 |
| Upper GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Septic shock | Renal and urinary disorders | Systematic Assessment | Infected renal cyst |
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| Surgical Site Infection | Infections and infestations | Systematic Assessment |
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| Post-op bleeding | Injury, poisoning and procedural complications | Systematic Assessment | Returned to OR for ligation of bleeder from rectus muscle |
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| Myocardial Infarct/cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Post-op respiratory failure requiring endotracheal intubation |
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| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
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| Seroma | Surgical and medical procedures | Systematic Assessment |
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| Recurrence | Surgical and medical procedures | Systematic Assessment |
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| Alcohol withdrawal | General disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
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| 240+ minutes |
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| No |
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| Do you have physical symptoms or pain at the site? |
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| Have you had any other abdominal surgery since your hernia operation? |
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| Severe |
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| Very Severe |
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| How intense was your average pain? |
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| What is your level of pain right now? |
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| Slightly agree |
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| Moderately agree |
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| Strongly agree |
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| My abdominal wall causes me physical pain. |
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| My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. |
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| My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. |
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| My abdominal wall interferes when I walk or climb stairs. |
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| My abdominal wall interferes when I dress myself, take showers and cook. |
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| My abdominal wall interferes with my sexual activity. |
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| I often stay at home because of my abdominal wall. |
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| I accomplish less at work because of my abdominal wall. |
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| My abdominal wall affects how I feel every day. |
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| I often feel blue because of my abdominal wall. |
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