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NCT04392583 · ClinicalTrials.gov registry record
Safety and Performance of ENTACT Septal Staple System for Septoplasty
A clinical trial, sponsored by Smith & Nephew.
- Completed
- Registry status
- 40
- Enrollment target
NCT04392583 is a clinical trial that has completed, run by Smith & Nephew. The registered enrollment target is 40 participants.
The verdict
NCT04392583 has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in Europe (data may be used to support registrations on other countries as well).
Interventions
- DEVICE ENTACT Septal Staple system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2021-06-25 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04392583
The ClinicalTrials.gov registry entry for NCT04392583 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Smith & Nephew, which has 72 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ENTACT Septal Staple system is the first listed.
NCT04392583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04392583 about?
NCT04392583 is a clinical study titled "Safety and Performance of ENTACT Septal Staple System for Septoplasty". This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in ...
What is the current status of trial NCT04392583?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2020-10-22. Estimated completion is 2021-06-25.
What interventions are being tested in trial NCT04392583?
The interventions under investigation include: ENTACT Septal Staple system (DEVICE).
Who is sponsoring clinical trial NCT04392583?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
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