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This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
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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 |
|---|---|---|
| Hernia recurrence | Incidence of radiographic recurrence at 24 months, defined as > 2cm above the hiatus via barium swallow. | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early post-operative complications | Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair | Occurring within the first 3 months of the hiatal hernia repair |
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Inclusion Criteria:
Exclusion Criteria (Baseline):
Exclusion Criteria (Intra-operative):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa LaMantia, MA | Contact | 757-761-4922 | mlamantia@telabio.com | |
| Danielle Campbell | Contact | 717-676-2589 | dcampbell@telabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Health | Recruiting | Mobile | Alabama | 36617 | United States |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| The University of Texas at Austin - Dell Medical School | Recruiting | Austin | Texas | 78712 | United States |
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