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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: Completed NA study, sponsored by Tela Bio.
NCT03074474 is a NA study that has completed, run by Tela Bio. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications \<90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.
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 |
What the finished NCT03074474 record still lists
NCT03074474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which OviTex 1S Permanent is the first listed.
NCT03074474 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03074474's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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