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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OviTex Reinforced Tissue Matrix | Other | This is a single-arm study. All study subjects will receive OviTex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OviTex Reinforced Tissue Matrix | Device | All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists. |
| Measure | Description | Time Frame |
|---|---|---|
| Early surgical site occurrences or wound related events | Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site | occurring within the first 3 months of the ventral or inguinal hernia repair |
| Early post-operative complications | Incidence of other early post-operative complications | occurring within the first 3 months of the ventral or inguinal hernia repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Late surgical site occurrences or wound related events | Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site | occurring > 3 months after index surgery |
| Late post-operative complications |
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Inclusion Criteria:
Exclusion Criteria at Baseline:
Exclusion Criteria Intraoperative:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa LaMantia | Contact | 757-761-4922 | mlamantia@telabio.com | |
| Danielle Campbell | Contact | 717-676-2589 | dcampbell@telabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Slayden, MD | St. Lukes Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Recruiting | Mobile | Alabama | 36617 | United States |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Incidence of other late post-operative complications
| occurring > 3 months after index surgery. |
| Patient Reported Outcomes | Patient Reported Outcomes (QoL and pain assessments) | Assessed at day 30, day 90, 12 months, and 24 months post-op |
| Hernia Recurrence | True hernia recurrence at the site of surgery | at post-operative day 90 and months 12 and 24 |
| SurgOne | Active, not recruiting | Denver | Colorado | 802210 | United States |
| GenesisCare | Terminated | Destin | Florida | 325541 | United States |
| Surgical Healing Arts Center | Terminated | Fort Myers | Florida | 33912 | United States |
| St. Luke's Hospital | Active, not recruiting | Overland Park | Kansas | 66213 | United States |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Munson Healthcare | Recruiting | Traverse City | Michigan | 49684 | United States |
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| St. Francis Hospital | Withdrawn | Roslyn | New York | 11576 | United States |
| Mohawk Valley Health System | Withdrawn | Utica | New York | 13502 | United States |
| Houston Methodist | Active, not recruiting | Houston | Texas | 77030 | United States |