Safety and Performance of ENTACT Septal Staple System for Septoplasty
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
1 other identifier
observational
40
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2021
CompletedResults Posted
Study results publicly available
May 18, 2022
CompletedJune 15, 2022
May 1, 2022
7 months
May 13, 2020
February 28, 2022
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
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)
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)
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)
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)
Day: 5, 21, and 42
- +4 more secondary outcomes
Study Arms (1)
Device: ENTACT Septal Staple
Septoplasty
Interventions
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.
Eligibility Criteria
Population needing septoplasty
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
ENT and Allergy Associates of Florida
Boca Raton, Florida, 33487, United States
South Florida Sinus and Allergy Center
Fort Lauderdale, Florida, 33301, United States
Beacon Medical Group Specialist
Elkhart, Indiana, 46514, United States
Related Publications (1)
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.
PMID: 24039176BACKGROUND
Limitations and Caveats
No limitations reported
Results Point of Contact
- Title
- Judith Horner
- Organization
- Smith+Nephew, Inc
Study Officials
- STUDY DIRECTOR
Sharron E McCulloch, MS
Smith & Nephew, Inc.
- STUDY CHAIR
Stephan Mangin
Smith & Nephew, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 19, 2020
Study Start
October 22, 2020
Primary Completion
June 2, 2021
Study Completion
June 25, 2021
Last Updated
June 15, 2022
Results First Posted
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share