Safety and Performance of ENTACT Septal Staple System for Septoplasty

Completed

• Conditions: Septoplasty
• Interventions: Device: ENTACT Septal Staple system

• Registration Number: NCT04392583
• Lead Sponsor: Smith & Nephew, Inc.

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 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.

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Study Start: 2020-10-22
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-25
• Results First Submitted: 2022-02-28
• Results First Submitted QC: 2022-02-28
• Status Verified: 2022-05
• Results First Posted: 2022-05-18
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

The patient will be eligible for the study if he or she meets all of the following inclusion criteria at the baseline screening:

1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB);
2. Clinically significant deviation of the nasal septum;
3. Willing and able to make all required study visits;
4. Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)

Exclusion Criteria

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:

1. Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
2. Traditional suturing techniques are necessary;
3. Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
4. Known to be allergic to foreign body of materials of investigational product;
5. Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
6. Pregnancy at time of procedure;
7. Presence of infection at the site;
8. Severe drug and alcohol abusers;
9. Autoimmune disease deemed clinically significant by Principal Investigator (PI).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: ENTACT Septal Staple	ENTACT Septal Staple system	Septoplasty

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit	21 days	At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no); * Complete coaptation of perichondrial flaps on septum wall (yes/no); * Absence of significant local tissue reaction at the staple site (yes/no); * Absence of hematoma swelling at the staple site (yes/no); * No need for re-intervention at the surgery site (yes/no); If all the answers to the questions above were "YES" then clinical success was inferred (if any answer was "NO" then repair failure was inferred).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)	Day: 5, 21, and 42	At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Complete coaptation of perichondrial flaps on septum wall.
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)	Day: 5, 21, and 42	At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Absence of hematoma swelling at the staple site.
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)	Day: 5, 21, and 42	At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Absence of significant local tissue reaction at the staple site.
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)	Day: 5, 21, and 42	At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": No need for re-intervention at the surgery site.
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits	Day: 0 (Screening), 5, 21 and 42	The Nasal Obstruction Symptom Evaluation (NOSE) scale is a patient reported outcome (PRO). The NOSE Scale allows participants to quantify their symptoms based on the severity of their nasal obstruction/congestion. The NOSE score range was 0-100 were 0 represented no obstruction (i.e., better outcome) and 100 represented extreme obstruction (i.e., worse outcome).
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)	Day: 5, 21, and 42	At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Septum wall straight appearance.
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits	Day: 0 (Screening), 5, 21 and 42	The Visual Analog Scale (VAS) for pain is a continuous scale completed by the participant who is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Scores range from 0-100 where a score of 0 represented no pain and a score of 100 indicated the worst pain possible.
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations	During procedure, up to 306 seconds	Intra-operative time to deploy staples overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in seconds between start of closure to when the stapler was handed back to the scrub nurse.
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations	During procedure, up to 97 minutes	Intra-operative surgery duration overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in minutes between start of the procedure and when the drapes are removed from the patient.

Trial Locations

Locations (3)

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