Status:
COMPLETED
Safety and Performance of ENTACT Septal Staple System for Septoplasty
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Septoplasty
Eligibility:
All Genders
Brief 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 pur...
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 v...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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).
Key Trial Info
Start Date :
October 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04392583
Start Date
October 22 2020
End Date
June 25 2021
Last Update
June 15 2022
Active Locations (3)
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1
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States, 33487
2
South Florida Sinus and Allergy Center
Fort Lauderdale, Florida, United States, 33301
3
Beacon Medical Group Specialist
Elkhart, Indiana, United States, 46514