Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® (ECH2O2)

Tela Bio

Status: Enrolling

Conditions: Hiatal Hernia

Treatments: Device: OviTex Reinforced Tissue Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT07070115

TB_04

Details and patient eligibility

About

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

Full description

This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 133 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.

Enrollment: 133 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

OviTex Reinforced Tissue Matrix

Other group

Description:

This is a single-arm study. All study subjects will receive OviTex.

Treatment:

Device: OviTex Reinforced Tissue Matrix