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| ID | Type | Description | Link |
|---|---|---|---|
| 05-003 |
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| Name | Class |
|---|---|
| Cook Biotech Incorporated | INDUSTRY |
| MED Institute, Incorporated | INDUSTRY |
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Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Biodesign IHM Graft placement |
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| 2 | Active Comparator | Polypropylene mesh placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign IHM | Device | Biodesign IHM is placed to reinforce the hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Inguinal Hernia Recurrence | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Timmons, M.D. | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
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| Label | URL |
|---|---|
| Biologic vs Synthetic Inguinal Hernia Repair: 1-year Results of a Randomized Double-Blinded Trial | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biodesign IHM Graft | Biodesign Inguinal Hernia Matrix (IHM) |
| FG001 | Polypropylene Mesh | Synthetic polypropylene mesh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biodesign IHM Graft | Biodesign Inguinal Hernia Matrix (IHM) |
| BG001 | Polypropylene Mesh | Synthetic polypropylene mesh |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Patients With Inguinal Hernia Recurrence | Posted | Number | participants | 1 year |
|
|
12 months
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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 | Biodesign IHM Graft | Biodesign Inguinal Hernia Matrix (IHM) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma requiring hospitalization | Vascular disorders | Systematic Assessment | unrelated to the device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech Incorporated | 765-497-3355 | jhodde@cookbiotech.com |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Polypropylene mesh | Device | Polypropylene mesh is used to reinforce the hernia repair. |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 7 |
| 45 |
| 18 |
| 45 |
| EG001 | Polypropylene Mesh | Synthetic polypropylene mesh | 5 | 50 | 15 | 50 |
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| Urinary tract infection (UTI) requiring hospitalization | Renal and urinary disorders | Systematic Assessment | unrelated to the device |
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| MI resulting in death | Cardiac disorders | Systematic Assessment | unrelated to the device |
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| Scrotal hematoma requiring hospitalization | Vascular disorders | Systematic Assessment | unrelated to the device |
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| Bradycardia during hernia repair | Cardiac disorders | Systematic Assessment | unrelated to the device |
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| Right inguinal pain, inflammation, and tenderness | Infections and infestations | Systematic Assessment | Requiring hospitalization - possibly related to the device |
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| Left groin pain and scrotal swelling | Infections and infestations | Systematic Assessment | Requiring hospitalization - possibly related to the device |
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| Diverticulitis and prostatitis requiring hospitalization | Infections and infestations | Systematic Assessment | unrelated to the device |
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| Substantial bleeding with central-line placement | Injury, poisoning and procedural complications | Systematic Assessment | unrelated to the device |
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| Motorcycle accident resulting in death | General disorders | Systematic Assessment | unrelated to the device |
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| Severe pain requiring hospitalization | Surgical and medical procedures | Systematic Assessment | unrelated to the device |
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| Urinary retention requiring overnight observation | Renal and urinary disorders | Systematic Assessment | unrelated to the device |
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| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Seroma | Surgical and medical procedures | Systematic Assessment |
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| Neuralgia | Nervous system disorders | Systematic Assessment |
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| Testicular problems | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Incisional pain | Surgical and medical procedures | Systematic Assessment |
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| Surgical site reaction | Surgical and medical procedures | Systematic Assessment |
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