N/A
N=40
Safety and Performance of ENTACT Septal Staple System for Septoplasty
Septoplasty
Bottom Line
View on ClinicalTrials.gov: NCT04392583 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: 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 — 94.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ENTACT Septal Staple system (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
94.7 | — |
| SECONDARY Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO) |
34; 3; 36; 2; 38; 1 | — |
| SECONDARY Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO) |
35; 2; 38; 0; 39; 0 | — |
| SECONDARY 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) |
35; 2; 38; 0; 39; 0 | — |
| SECONDARY Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO) |
37; 0; 38; 0; 39; 0 | — |
| SECONDARY Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO) |
37; 0; 38; 0; 38; 1 | — |
| SECONDARY Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits |
69.2; 62.5; 39.9; 33.2 | — |
| SECONDARY Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits |
9.6; 13.9; 6.0; 2.0 | — |
| SECONDARY Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations |
43.7; 64.9; 20.4; 67.0; 25.0 | — |
| SECONDARY Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations |
57.6; 82.2; 28.1; 125.0; 22.0 | — |
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).
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04392583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.