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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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2020-10-22
Est. Completion 2021-06-25

Sponsor

Smith & Nephew

72 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.