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).
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 Type
OBSERVATIONAL
Enrollment
40
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.
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
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).
Time frame: 21 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During procedure, up to 306 seconds