Trial Outcomes & Findings for Post-market Study of the Biodesign Hernia Graft (NCT NCT04294446)
NCT ID: NCT04294446
Last Updated: 2026-03-12
Results Overview
Hernia recurrence through 1-year follow-up
Recruitment status
TERMINATED
Target enrollment
74 participants
Primary outcome timeframe
1-year
Results posted on
2026-03-12
Participant Flow
21 patients that were consented failed the screen.
Participant milestones
| Measure |
All Participants
All consented patients
|
|---|---|
|
Enrollment
STARTED
|
74
|
|
Enrollment
1 month follow-up completed
|
74
|
|
Enrollment
COMPLETED
|
47
|
|
Enrollment
NOT COMPLETED
|
27
|
|
6- month follow-up completed
STARTED
|
47
|
|
6- month follow-up completed
COMPLETED
|
40
|
|
6- month follow-up completed
NOT COMPLETED
|
7
|
|
1 year follow-up completed
STARTED
|
40
|
|
1 year follow-up completed
COMPLETED
|
40
|
|
1 year follow-up completed
NOT COMPLETED
|
0
|
|
2-year follow-up completed
STARTED
|
40
|
|
2-year follow-up completed
COMPLETED
|
25
|
|
2-year follow-up completed
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-market Study of the Biodesign Hernia Graft
Baseline characteristics by cohort
| Measure |
All Participants That Completed 1 Month Follow-up
n=47 Participants
All participants that completed at least the 1 month follow-up
|
|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 10.7 • n=9 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
46 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=9 Participants
|
|
Number of patients with hernia
|
47 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 1-yearHernia recurrence through 1-year follow-up
Outcome measures
| Measure |
Population
n=40 Participants
One group, post-market evaluation.
|
|---|---|
|
Hernia Recurrence
|
3 Participants
|
SECONDARY outcome
Timeframe: 2-yearSummarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates)
Outcome measures
| Measure |
Population
n=24 Participants
One group, post-market evaluation.
|
|---|---|
|
Device-, Procedure-, and Hernia-related Adverse Event Rates
|
29 events
|
SECONDARY outcome
Timeframe: 2-yearAssess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up
Outcome measures
| Measure |
Population
n=25 Participants
One group, post-market evaluation.
|
|---|---|
|
Hernia Recurrence Rate Through 2-year Follow-up
|
2 Hernia Recurrence
|
SECONDARY outcome
Timeframe: During operationWhat was the operation time for the ventral hernia repair for patients who had a follow-up at least 1 month after procedure.
Outcome measures
| Measure |
Population
n=47 Participants
One group, post-market evaluation.
|
|---|---|
|
Operative Times
240+ minutes
|
35 Participants
|
|
Operative Times
120-179 minutes
|
3 Participants
|
|
Operative Times
180-239 minutes
|
8 Participants
|
|
Operative Times
60-119 minutes
|
1 Participants
|
SECONDARY outcome
Timeframe: 2-yearNumber of patients with serious adverse events that required a hospital stay
Outcome measures
| Measure |
Population
n=10 Participants
One group, post-market evaluation.
|
|---|---|
|
Hospital Stays for Serious Adverse Events
|
9 Participants
6.8
|
SECONDARY outcome
Timeframe: From date of hospitalization for SAE. Patients were followed up to 2 years.Hospitalization times for patients with related Serious Adverse Events (SAEs). For patients who were followed up to 2 years after procedure.
Outcome measures
| Measure |
Population
n=9 Participants
One group, post-market evaluation.
|
|---|---|
|
Hospitalization Times for Related Serious Adverse Events (SAEs)
|
9.9 days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 2-yearPatient-reported quality of life assessed by completion of a questionaire
Outcome measures
| Measure |
Population
n=25 Participants
One group, post-market evaluation.
|
|---|---|
|
Patient-reported Quality of Life: Yes/No
Do you feel like your hernia has come back? · Yes
|
3 Participants
|
|
Patient-reported Quality of Life: Yes/No
Do you feel like your hernia has come back? · No
|
22 Participants
|
|
Patient-reported Quality of Life: Yes/No
Have you had any other abdominal surgery since your hernia operation? · Yes
|
0 Participants
|
|
Patient-reported Quality of Life: Yes/No
Have you had any other abdominal surgery since your hernia operation? · No
|
25 Participants
|
|
Patient-reported Quality of Life: Yes/No
Do you feel or see a bulge? · Yes
|
3 Participants
|
|
Patient-reported Quality of Life: Yes/No
Do you feel or see a bulge? · No
|
22 Participants
|
|
Patient-reported Quality of Life: Yes/No
Do you have physical symptoms or pain at the site? · Yes
|
5 Participants
|
|
Patient-reported Quality of Life: Yes/No
Do you have physical symptoms or pain at the site? · No
|
20 Participants
|
SECONDARY outcome
Timeframe: 2-year follow-upPatient reported quality of life related to pain
Outcome measures
| Measure |
Population
n=25 Participants
One group, post-market evaluation.
|
|---|---|
|
Patient Reported Quality of Life-Pain Questions
How intense was your pain at its worse? · No pain
|
18 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your pain at its worse? · Mild
|
1 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your pain at its worse? · Moderate
|
3 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your pain at its worse? · Severe
|
2 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your pain at its worse? · Very Severe
|
1 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your average pain? · No pain
|
19 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your average pain? · Mild
|
2 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your average pain? · Moderate
|
4 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your average pain? · Severe
|
0 Participants
|
|
Patient Reported Quality of Life-Pain Questions
How intense was your average pain? · Very Severe
|
0 Participants
|
|
Patient Reported Quality of Life-Pain Questions
What is your level of pain right now? · No pain
|
22 Participants
|
|
Patient Reported Quality of Life-Pain Questions
What is your level of pain right now? · Mild
|
1 Participants
|
|
Patient Reported Quality of Life-Pain Questions
What is your level of pain right now? · Moderate
|
2 Participants
|
|
Patient Reported Quality of Life-Pain Questions
What is your level of pain right now? · Severe
|
0 Participants
|
|
Patient Reported Quality of Life-Pain Questions
What is your level of pain right now? · Very Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: 2-year follow-uppatient reported quality of life related to abdominal wall
Outcome measures
| Measure |
Population
n=25 Participants
One group, post-market evaluation.
|
|---|---|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Slightly agree
|
3 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Moderately agree
|
3 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Strongly agree
|
9 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Strongly disagree
|
15 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Moderately disagree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Slightly agree
|
5 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform moderate activities, e.g., bowling or bending over. · Strongly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Strongly disagree
|
20 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Moderately disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Slightly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Moderately agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I walk or climb stairs. · Strongly agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Strongly disagree
|
22 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Moderately disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Slightly agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Moderately agree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I dress myself, take showers and cook. · Strongly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Strongly disagree
|
21 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Moderately disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Slightly agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Moderately agree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes with my sexual activity. · Strongly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Strongly disagree
|
21 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Moderately disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Slightly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often stay at home because of my abdominal wall. · Strongly agree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Strongly disagree
|
21 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Moderately disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Slightly agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I accomplish less at work because of my abdominal wall. · Strongly agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Strongly disagree
|
17 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Moderately disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Slightly disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Slightly agree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall affects how I feel every day. · Strongly agree
|
6 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Strongly disagree
|
18 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Moderately disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Slightly disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Slightly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Moderately agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
I often feel blue because of my abdominal wall. · Strongly agree
|
2 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Strongly disagree
|
16 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Moderately disagree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Slightly agree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall has a huge impact on my health. · Strongly agree
|
7 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Strongly disagree
|
16 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Moderately disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Slightly disagree
|
0 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Slightly agree
|
5 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Moderately agree
|
1 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall causes me physical pain. · Strongly agree
|
3 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Strongly disagree
|
9 Participants
|
|
Patient Reported Quality of Life-abdominal Wall
My abdominal wall interferes when I perform strenuous activities, e.g., heavy lifting. · Moderately disagree
|
1 Participants
|
Adverse Events
All Participants
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=47 participants at risk
All participants that had follow-ups
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Gastrointestinal disorders
Upper GI bleed
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Renal and urinary disorders
Septic shock
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Infections and infestations
Surgical Site Infection
|
8.5%
4/47 • Through the 2-year follow-up period
|
|
Injury, poisoning and procedural complications
Post-op bleeding
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Cardiac disorders
Myocardial Infarct/cardiac arrest
|
4.3%
2/47 • Through the 2-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Gastrointestinal disorders
Appendicitis
|
2.1%
1/47 • Through the 2-year follow-up period
|
Other adverse events
| Measure |
All Participants
n=47 participants at risk
All participants that had follow-ups
|
|---|---|
|
Infections and infestations
Surgical Site Infection
|
12.8%
6/47 • Through the 2-year follow-up period
|
|
Surgical and medical procedures
Seroma
|
6.4%
3/47 • Through the 2-year follow-up period
|
|
Surgical and medical procedures
Recurrence
|
8.5%
4/47 • Through the 2-year follow-up period
|
|
General disorders
Alcohol withdrawal
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.3%
2/47 • Through the 2-year follow-up period
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/47 • Through the 2-year follow-up period
|
|
Cardiac disorders
Atrial Fibrillation
|
2.1%
1/47 • Through the 2-year follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place