NCT04392583

Safety and Performance of ENTACT Septal Staple System for Septoplasty

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
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Septoplasty

Interventions

Type	Name	Description
DEVICE	ENTACT Septal Staple system	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.

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-06-02
• Completion: 2021-06-25
• First posted: 2020-05-19
• Last updated: 2022-06-15
• Results posted: 2022-05-18

Locations

3 sites across 1 country: United States