Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
NCT ID: NCT07070115
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
173 participants
INTERVENTIONAL
2025-07-25
2032-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
OviTex Reinforced Tissue Matrix
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.
Interventions
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OviTex Reinforced Tissue Matrix
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.
Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
3. Patient is at least 22 years old at the time of surgery.
4. Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
5. Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
Exclusion Criteria
2. Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
3. Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
4. Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
5. Patient is a current nicotine user (including smokeless, vaporized, etc.)
6. Patient has a history of illicit drug or alcohol abuse (in the last three years).
7. Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
8. Patient has an allergy to barium.
9. Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
10. Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
11. Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.
12. Patient had previous surgery at the gastroesophageal junction.
13. Patient had a prior hiatal hernia repair.
14. Patient has an incarcerated hernia that requires emergent intervention.
15. Patient is a prisoner.
1. Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
2. Surgery requires the use of an additional mesh device or a pledget for reinforcement.
3. Surgery includes the use of an anti-reflux implantable device (LINX, etc.).
4. Surgery performed as an open procedure.
5. Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.
22 Years
ALL
No
Sponsors
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Tela Bio Inc
INDUSTRY
Responsible Party
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Locations
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University of South Alabama Health
Mobile, Alabama, United States
The University of Texas at Austin - Dell Medical School
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TB_04
Identifier Type: -
Identifier Source: org_study_id
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