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NCT03074474 · ClinicalTrials.gov registry record · NA
Ventral Hernia Study Using OviTex Reinforced Bioscaffold
A NA study, sponsored by Tela Bio.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT03074474 is a NA study that has completed, run by Tela Bio. The registered enrollment target is 92 participants.
The verdict
NCT03074474, a NA study, has completed, sponsored by Tela Bio.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE OviTex 1S Permanent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2021-08-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03074474
The ClinicalTrials.gov registry entry for NCT03074474 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tela Bio, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OviTex 1S Permanent is the first listed.
NCT03074474 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03074474 about?
NCT03074474 is a clinical study titled "Ventral Hernia Study Using OviTex Reinforced Bioscaffold". 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 part...
What is the current status of trial NCT03074474?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2017-04-24. Estimated completion is 2021-08-08.
What interventions are being tested in trial NCT03074474?
The interventions under investigation include: OviTex 1S Permanent (DEVICE).
Who is sponsoring clinical trial NCT03074474?
This trial is sponsored by Tela Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.
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