Recruiting

OviTex Mesh

Sponsor:

Tela Bio Inc

Code:

NCT04779918

Conditions

Hernia, Ventral

Hernia, Inguinal

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

OviTex Reinforced Tissue Matrix

Study Details

Brief summary:

This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.

Conditions

Hernia, Ventral

Hernia, Inguinal

Study ID

NCT04779918

Start date

Apr 29, 2021

Status verified date

Apr, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
3. The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
4. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
5. Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
7. Subject is at least 21 years old.
8. Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.

Exclusion Criteria at Baseline:

1. Subject has a BMI of > 40
2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
4. Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
5. Subject has recent history of drug or alcohol abuse (in last 3 years).
6. Subject has an allergy to ovine-derived products.
7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
8. Subject has a strangulated hernia.

Exclusion Criteria Intraoperative:

1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
2. Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: OviTex Reinforced Tissue Matrix

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

Interventions

OviTex 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.

Primary outcome measure

  • Early surgical site occurrences or wound related events [ Time Frame: occurring within the first 3 months of the ventral or inguinal hernia repair ]
  • Early post-operative complications [ Time Frame: occurring within the first 3 months of the ventral or inguinal hernia repair. ]

Central Contacts and Locations

Central contacts

Locations

University of South Alabama

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Principal Investigator:

Daniel McMahon, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Farid Kehdy, MD

Munson Healthcare

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Kelly VanSchouwen

kelly@researchtex.com

Principal Investigator:

Joel Strehl, DO

More Information

Sponsor

Tela Bio Inc

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • use of mesh
  • robotic hernia repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tela Bio Inc on 2026-05-05.