Clinical trial NCT04392583: Safety and Performance of ENTACT Septal Staple System for Septoplasty
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septoplasty
Keywords: Septoplasty
ENTACT Septal Stapler
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population needing septoplasty

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.

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:

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).

Primary outcomes:
measure: 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
timeFrame: 21 days
Secondary outcomes:
measure: Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
timeFrame: Day: 5, 21, and 42
measure: Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
timeFrame: Day: 5, 21, and 42
measure: 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)
timeFrame: Day: 5, 21, and 42
measure: Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
timeFrame: Day: 5, 21, and 42
measure: Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
timeFrame: Day: 5, 21, and 42
measure: Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
timeFrame: Day: 0 (Screening), 5, 21 and 42
measure: Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
timeFrame: Day: 0 (Screening), 5, 21 and 42
measure: Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
timeFrame: During procedure, up to 97 minutes
measure: Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
timeFrame: During procedure, up to 306 seconds
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Sinus and Allergy Center
state: Florida
city: Elkhart
country: United States
facility: Beacon Medical Group Specialist
state: Indiana
Study officials:
affiliation: Smith & Nephew, Inc.
name: Sharron E McCulloch, MS
role: STUDY_DIRECTOR
affiliation: Smith & Nephew, Inc.
name: Stephan Mangin
role: STUDY_CHAIR
References:
citation: Sowerby LJ, Wright ED. A comparison of septal stapler to suture closure in septoplasty: a prospective, randomized trial evaluating the effect on operative time. Int Forum Allergy Rhinol. 2013 Nov;3(11):911-4. doi: 10.1002/alr.21209. Epub 2013 Aug 26.