An interventional study of OviTex Reinforced Tissue Matrix in Hernia, Ventral and Hernia, Inguinal, sponsored by Tela Bio Inc. Recruiting at 10 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Tela Bio Inc · Not applicable, Interventional, and Treatment
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.
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 160 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →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.
Inclusion Criteria:
Exclusion Criteria at Baseline:
Exclusion Criteria Intraoperative:
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single-arm study. All study subjects will receive OviTex.
Device: 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.
Early surgical site occurrences or wound related events
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair
Early post-operative complications
Incidence of other early post-operative complications
Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair.
Late surgical site occurrences or wound related events
Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site
Time frame: occurring > 3 months after index surgery
Late post-operative complications
Incidence of other late post-operative complications
Time frame: occurring > 3 months after index surgery.
Patient Reported Outcomes
Patient Reported Outcomes (QoL and pain assessments)
Time frame: Assessed at day 30, day 90, 12 months, and 24 months post-op
Hernia Recurrence
True hernia recurrence at the site of surgery
Time frame: at post-operative day 90 and months 12 and 24
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Plan to share: No
No publications or documents are linked to this record.
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Tela Bio Inc