SeptoplastyNCT04392583

Safety and Performance of ENTACT Septal Staple System for Septoplasty

An observational study of Septoplasty, run by Smith & Nephew, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Septoplasty
What is being tested?: ENTACT Septal Staple system
Type of treatment: Medical device
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: 22 Oct 2020to 25 Jun 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Population needing septoplasty

Who may be able to join

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)

Who cannot join

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;

Show all 10Show fewer

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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

ENT and Allergy Associates of Florida
Boca Raton, Florida, 33487
Beacon Medical Group Specialist
Elkhart, Indiana, 46514
South Florida Sinus and Allergy Center
Fort Lauderdale, Florida, 33301

Other trials in United States

About this study

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

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).

Read the 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.

Conditions: Septoplasty
Being tested: ENTACT Septal Staple system
Keywords: Septoplasty, ENTACT Septal Stapler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENTACT Septal Staple systemDevice
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.

Study groups in NCT04392583
Study group	Role	What they receive
Device: ENTACT Septal Staple		Septoplasty Receives: Device: ENTACT Septal Staple system

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 21 days

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During procedure, up to 306 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 202025 Jun 2021

First posted19 May 2020
Study start22 Oct 2020
Primary completion2 Jun 2021
Study completion25 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SeptoplastyStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04392583
Sponsor's protocol ID: ENTACT.ENT.PRO.SEP.2019.05
Status last verified: May 2022
First submitted: 13 May 2020
Last updated: 15 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24039176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
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Impact of Septoplasty on Headache
Impact of Septoplasty on Headache
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Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty
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Cold Dissection vs Electrocautry on TCR in Septoplasty
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Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
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All Septoplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04392583
Acronym / sponsor ID: ENTACT.ENT.PRO.SEP.2019.05
Conditions: Septoplasty
Keywords: Septoplasty, ENTACT Septal Stapler
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 22 Oct 2020 (actual)
Primary completion: 2 Jun 2021 (actual)
Study completion: 25 Jun 2021 (actual)
First posted: 19 May 2020 (actual)
Results: Posted 18 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Device: ENTACT Septal Staple	–	Device: ENTACT Septal Staple systemSeptoplasty

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Population needing septoplasty

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ENTACT Septal Staple systemThe 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.	Device	Device: ENTACT Septal Staple

Primary outcome

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
Time frame: 21 days
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).

9 secondary outcomes

Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
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)
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)
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)
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)
Time frame: Day: 5, 21, and 42
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
Time frame: Day: 0 (Screening), 5, 21 and 42
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
Time frame: Day: 0 (Screening), 5, 21 and 42
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Time frame: During procedure, up to 97 minutes
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Time frame: During procedure, up to 306 seconds

Results and safety

Results posted to the registry on 18 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device: ENTACT Septal Staple	40	39

Primary outcome: 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

Time frame: 21 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Device: ENTACT Septal Staple n = 38
Value	94.7 (82 to 99)

Population analysed: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device: ENTACT Septal Staple	0 of 40 (0%)	4 of 40 (10%)	0 of 40

Limitations and caveats (from the sponsor): No limitations reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24039176Sowerby 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.
Individual participant dataSharing planned: No

Related trials for Septoplasty

Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Recruiting
Impact of Septoplasty on Headache
Impact of Septoplasty on Headache
Active, not recruitingObservational study
Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty
ENT Disease
Active, not recruitingObservational study
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Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharron E McCulloch, MS study director

Smith & Nephew, Inc.

Stephan Mangin study chair

Smith & Nephew, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Septoplasty, run by Smith & Nephew, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.