ClinicalTrials.gg
RecruitingNCT07070115ECH2O2Updated Aug 18, 2026

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

An interventional study of OviTex Reinforced Tissue Matrix in Hiatal Hernia, sponsored by Tela Bio Inc. Recruiting at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Tela Bio Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hiatal Hernia

Keywords

  • hiatal
  • hernia
  • reinforced tissue matrix
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 173 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Tela Bio Inc is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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 (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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
173 participants (estimated)

Study arms

  • Other
    OviTex Reinforced Tissue Matrix

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

    Device: OviTex Reinforced Tissue Matrix

Interventions

  • DeviceOviTex 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.

06

What researchers measure

Primary outcomes

  1. Hernia recurrence

    Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.

    Time frame: At 24 months

Secondary outcomes

  1. Early post-operative complications

    Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair

    Time frame: Occurring within the first 3 months of the hiatal hernia repair

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07070115
Lead sponsor
Tela Bio Inc
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Jul 25, 2025
Primary completion
Dec 31, 2031 (estimated)
Completion
Jul 31, 2032 (estimated)
Last update
Aug 18, 2026

Study contacts

Melissa LaMantia, MA
Contact
mlamantia@telabio.com
757-761-4922
Danielle Campbell
Contact
dcampbell@telabio.com
717-676-2589

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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