Hiatal Hernia
Conditions
Keywords
hiatal, hernia, reinforced tissue matrix
Brief summary
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Detailed description
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.
Interventions
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.
Sponsors
Tela Bio Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | At 24 months | Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early post-operative complications | Occurring within the first 3 months of the hiatal hernia repair | Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair |
Countries
United States
Contacts
CONTACTMelissa LaMantia, MA
CONTACTDanielle Campbell
Outcome results
None listed