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Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

RecruitingNAAges 22 Years - anyAllTela Bio Inc
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In plain words

What the trial is, and whether it could suit you

This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable. 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 (Baseline): 1. Patient has a Body Mass Index (BMI) of ≥ 35. 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. Exclusion Criteria (Intra-operative): 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.
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What it tests

  • OviTex Reinforced Tissue Matrix
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Where

5 sites
University of South Alabama Health
Mobile, United States
SurgOne, PC
Denver, United States
University of Kentucky
Lexington, United States
Wake Forest University Health Sciences
Charlotte, United States
The University of Texas at Austin - Dell Medical School
Austin, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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