Safety and Performance of ENTACT Septal Staple System for Septoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Septoplasty

Intervention / Treatment
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* Device: ENTACT Septal Staple system


Participation Criteria
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Eligibility Criteria
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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: 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 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: 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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device: ENTACT Septal Staple<br>Septoplasty | Device: ENTACT Septal Staple system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) | 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. | Day: 5, 21, and 42 | 
| Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) | 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. | Day: 5, 21, and 42 | 
| 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) | 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. | Day: 5, 21, and 42 | 
| Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | 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. | Day: 5, 21, and 42 | 
| Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) | 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. | Day: 5, 21, and 42 | 
| Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits | 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). | Day: 0 (Screening), 5, 21 and 42 | 
| Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits | 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. | Day: 0 (Screening), 5, 21 and 42 | 
| Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations | 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. | During procedure, up to 97 minutes | 
| Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations | 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. | During procedure, up to 306 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septoplasty, ENTACT Septal Stapler