NCT07070115

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
75mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jul 2025Jul 2032

First Submitted

Initial submission to the registry

July 3, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2032

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

6.4 years

First QC Date

July 3, 2025

Last Update Submit

February 5, 2026

Conditions

Hiatal Hernia

Keywords

hiatalherniareinforced tissue matrix

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

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

    At 24 months

Secondary Outcomes (1)

  • Early post-operative complications

    Occurring within the first 3 months of the hiatal hernia repair

Study Arms (1)

OviTex Reinforced Tissue Matrix

OTHER

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

Device: OviTex Reinforced Tissue Matrix

Interventions

OviTex Reinforced Tissue MatrixDEVICE

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.

OviTex Reinforced Tissue Matrix

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
  • Patient is at least 22 years old at the time of surgery.
  • Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
  • Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.

You may not qualify if:

  • Patient has a Body Mass Index (BMI) of ≥ 35.
  • Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
  • Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
  • Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
  • Patient is a current nicotine user (including smokeless, vaporized, etc.)
  • Patient has a history of illicit drug or alcohol abuse (in the last three years).
  • Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
  • Patient has an allergy to barium.
  • Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
  • Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
  • 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.
  • Patient had previous surgery at the gastroesophageal junction.
  • Patient had a prior hiatal hernia repair.
  • Patient has an incarcerated hernia that requires emergent intervention.
  • Patient is a prisoner.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Alabama Health

Mobile, Alabama, 36617, United States

RECRUITING

The University of Texas at Austin - Dell Medical School

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Hernia, HiatalHernia

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Melissa LaMantia, MA

CONTACT

757-761-4922mlamantia@telabio.com

Danielle Campbell

CONTACT

717-676-2589dcampbell@telabio.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 17, 2025

Study Start

July 25, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

July 31, 2032

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)