Safety and Performance of ENTACT Septal Staple System for Septoplasty

Septoplasty Clinical Trial

Official title:
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

Status Completed

Clinical Trial 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).

Clinical Trial Description

The primary objective of this study is to demonstrate clinical success of the ENTACT (Next Generation) resorbable septal staple system by examining the patient's nasal cavity at the 21 day follow-up visit. The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple. ;

Study Design

Related Conditions & MeSH terms

Septoplasty

Clinical Trial Details

NCT number	NCT04392583
Study type	Observational
Source	Smith & Nephew, Inc.
Contact
Status	Completed
Phase
Start date	October 22, 2020
Completion date	June 25, 2021

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04921462` - Silastic Sheet Usefulness Following Septoplasty	N/A
	Recruiting	`NCT04020367` - Validation of a Process for the Manufacture of Stem Cells Isolated From the Nasal Cavity for Innovative Cell Therapy of Traumatized Peripheral Nerves	N/A