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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: Completed study, sponsored by Smith & Nephew.
NCT04392583 is a clinical trial that has completed, run by Smith & Nephew. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were "YES" then clinical success was infe
Interventions
- DEVICE ENTACT Septal Staple system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2021-06-25 |
What the finished NCT04392583 record still lists
NCT04392583 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ENTACT Septal Staple system is the first listed.
NCT04392583 does not publish any study locations in the registry export this page uses.
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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