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Completed Not applicable Interventional Results available

Ventral Hernia Study Using OviTex Reinforced Bioscaffold

ClinicalTrials.gov ID: NCT03074474

Public ClinicalTrials.gov record NCT03074474. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 4:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

Study identification

NCT ID
NCT03074474
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Tela Bio Inc
Industry
Enrollment
92 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 24, 2017 (Actual)
Primary completion
Dec 8, 2019 (Actual)
Completion
Aug 8, 2021 (Actual)
Last update posted
Jun 13, 2023

2017 – 2021

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Scripps Clinic La Jolla California 92037 —
Sarasota Memorial Hospital Sarasota Florida 34239 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
St. Luke's Hospital South Overland Park Kansas 66213 —
Capital Health Trenton New Jersey 08638 —
St. Francis Hosptial Roslyn New York 11576 —
Comanche County Memorial Hospital Lawton Oklahoma 73505 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03074474, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 13, 2023 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03074474 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →