CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
ENTACT Septal Staple systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04392583
NCT04392583N/ACompleted
CompareCT.gov

A Prospective, Multi-center, Single Arm Post-market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of ENTACT™ (Next Generation) Resorbable Septal Staple System for Septoplasty

Smith & Nephew, Inc.·observational·Posted May 19, 2020·Updated Jun 15, 2022

In Brief

An observational study evaluating ENTACT Septal Staple system for Septoplasty. Completed, enrolled 40 participants across 3 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSeptoplasty
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 19, 2020
Enrollment StartOct 22, 2020
Primary CompletionJun 2, 2021
Study CompletionJun 25, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.1 years ago

Interventions

ENTACT Septal Staple systemdevice

The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.