RecruitingNot Applicable

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

United States160 participantsStarted 2021-04-29

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
. 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.
. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
. 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.
. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
. Subject is at least 21 years old.
. 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

. Subject has a BMI of \> 40

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Early surgical site occurrences or wound related events

Timeframe: occurring within the first 3 months of the ventral or inguinal hernia repair

Early post-operative complications

Timeframe: occurring within the first 3 months of the ventral or inguinal hernia repair.

Trial details

NCT IDNCT04779918

SponsorTela Bio Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-30

Contact for this trial

Melissa LaMantia

757-761-4922 mlamantia@telabio.com

View on ClinicalTrials.gov More Hernia, Ventral trials