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Robotic mesh may patch hernias better

NCT ID NCT04779918

Disease control Sponsor: Tela Bio Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a special surgical mesh called OviTex in people who need robotic hernia repair for ventral or inguinal hernias. Up to 160 participants will get the mesh and be followed for complications and hernia recurrence. The goal is to see if OviTex is safe and effective when used with robotic surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OviTex Reinforced Tissue Matrix (a surgical mesh device)
What this could lead to
If successful, this could show that OviTex is a safe and effective option for robotic hernia repair, reducing complications and recurrences.
What could go wrong
This is an early-stage study with no control group, so results may not prove OviTex is better than other meshes. Risks include infection, pain, or hernia return.
Why investors are watching

TELA Bio is a very small company, and its main product, OviTex, is a reinforced tissue matrix used in hernia repair. This trial tracks 160 patients who receive OviTex during ventral or inguinal hernia surgery, measuring post-operative complications and hernia recurrence. For a micro-cap company, this readout matters because it provides real-world evidence on whether the product works safely, which directly affects its reputation and future sales.

If it works: A positive result, showing low complication and recurrence rates, could strengthen confidence in OviTex among surgeons and support broader adoption. That could help TELA Bio grow its revenue from a product that is central to its business.

If it fails: If the trial shows high complication or recurrence rates, or if the company delays or stops the study, it could hurt the product's credibility and the company's prospects. Clinical trials often fail or produce mixed results, so investors should treat a negative outcome as a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal Hernia, Ventral

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hernia, inguinal Hernia, ventral

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GenesisCare

    TERMINATED

    Destin, Florida, 325541, United States

  • Houston Methodist

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Mohawk Valley Health System

    WITHDRAWN

    Utica, New York, 13502, United States

  • Munson Healthcare

    RECRUITING

    Traverse City, Michigan, 49684, United States

  • St. Francis Hospital

    WITHDRAWN

    Roslyn, New York, 11576, United States

  • St. Luke's Hospital

    ACTIVE_NOT_RECRUITING

    Overland Park, Kansas, 66213, United States

  • SurgOne

    ACTIVE_NOT_RECRUITING

    Denver, Colorado, 802210, United States

  • Surgical Healing Arts Center

    TERMINATED

    Fort Myers, Florida, 33912, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of South Alabama

    RECRUITING

    Mobile, Alabama, 36617, United States

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