RECRUITING

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Conditions

Hiatal Hernia hiatal hernia reinforced tissue matrix

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix

Quick Facts

Study Start:2025-07-25

Study Completion:2032-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07070115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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.
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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Melissa LaMantia, MA, PMP

CONTACT

757-761-4922

mlamantia@telabio.com

Danielle Campbell

CONTACT

717-676-2589

dcampbell@telabio.com

Study Locations (Sites)

The University of Texas at Austin - Dell Medical School

Austin, Texas, 78712

United States

Collaborators and Investigators

Sponsor: Tela Bio Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25

Study Completion Date2032-07-31

Study Record Updates

Study Start Date2025-07-25

Study Completion Date2032-07-31

Terms related to this study

Keywords Provided by Researchers

hiatal
hernia
reinforced tissue matrix

Additional Relevant MeSH Terms

Hiatal Hernia