Safety and Performance of ENTACT Septal Staple System for Septoplasty

Completed

Conditions studied: Septoplasty

In brief

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).

Key facts

Study ID

NCT04392583

Run by

Smith & Nephew, Inc.

People needed

40

Starts

2020-10-22

Expected to finish

2021-06-25

Last updated by the study team

2022-06-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient will be eligible for the study if he or she meets all of the following inclusion criteria at the baseline screening:
• Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB);
• Clinically significant deviation of the nasal septum;
• Willing and able to make all required study visits;
• Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)

You may not qualify if…

• The patient will be ineligible for the study if he or she meets any of the following exclusion criteria at the baseline screening or during surgery:
• Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
• Traditional suturing techniques are necessary;
• Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
• Known to be allergic to foreign body of materials of investigational product;
• Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
• Pregnancy at time of procedure;
• Presence of infection at the site;
• Severe drug and alcohol abusers;
• Autoimmune disease deemed clinically significant by Principal Investigator (PI).

Where it is running

• ENT and Allergy Associates of Florida — Boca Raton, Florida, United States
• South Florida Sinus and Allergy Center — Fort Lauderdale, Florida, United States
• Beacon Medical Group Specialist — Elkhart, Indiana, United States

Full record on ClinicalTrials.gov

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