MedTrace Logo

Safety and Performance of ENTACT Septal Staple System for Septoplasty

NCT04392583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-06-15

Study results available
· View outcomes & findings →

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).

Conditions

  • Septoplasty

Interventions

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharron E McCulloch, MS · Smith & Nephew, Inc.

  • Stephan Mangin · Smith & Nephew, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2021-06-02
Completion
2021-06-25

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392583 on ClinicalTrials.gov