Trial · NCT02291549

S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

NCT02291549, Phase 3, Completed, Intersect ENT; results first posted 2018-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps. Trials, record NCT02291549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291549

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
NCT number: NCT02291549
Status: Completed
Phases: Phase 3
Enrollment: 300 participants, actual
Lead sponsor: Intersect ENT
Conditions: Chronic Sinusitis, Nasal Polyposis
Interventions: S8 Sinus Implant, Mometasone furoate nasal spray, Sham
First posted: 2014-11-14
Last updated: 2018-08-15
Results first posted: 2018-07-09
Limitations and caveats: 1. The absence of a defined medical regimen prior to enrollment.~2. The clinical investigators performing assessment of indication for RESS at Day 90 were unblinded.~3. The relatively short duration of the trial (90 days).

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Nasal Obstruction/Congestion Score	Day 30	Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.
Primary	Bilateral Polyp Grade	Day 90	Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.
Secondary	Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)	Day 90	Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade \>= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.
Secondary	Ethmoid Sinus Obstruction	Day 90	Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction.
Secondary	Nasal Obstruction/Congestion Score	Day 90	Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.
Secondary	Decreased Sense of Smell Score	Day 90	Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.
Secondary	Facial Pain/Pressure Score	Day 90	Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Nasal Obstruction/Congestion Score	Day 30	Intent-to-treat population. Scoring for \>=4 days in 7 days before the baseline and Day 30 visits was required. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 4 (1.3%) participants (2 treatment, 2 control) with missing values at Day 30. No imputation of missing values was performed.	units on a scale	MEAN
PRIMARY	Bilateral Polyp Grade	Day 90	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)	Day 90	Intent-to-treat population, consisting of all patients in whom an implant or sham procedure was attempted. 2 participants did not complete Day 90 visit. No imputation of missing values was performed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Ethmoid Sinus Obstruction	Day 90	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Nasal Obstruction/Congestion Score	Day 90	Intent-to-treat population. Scoring for \>=4 of 7 days immediately preceding the baseline and Day 90 visits was required. There were 34 (11.3%) participants with missing scores: 23 treatment and 10 control at Day 90 and 1 (treatment) at baseline. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Decreased Sense of Smell Score	Day 90	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Facial Pain/Pressure Score	Day 90	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values: 3 at baseline (1 treatment, 1 control)) and 2 at Day 90 (1 treatment, 1 control) No imputation of missing values was performed.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Nasal Obstruction/Congestion Score	Treatment	Baseline	2.36	Standard Deviation 0.488	units on a scale
Nasal Obstruction/Congestion Score	Control	Baseline	2.35	Standard Deviation 0.479	units on a scale
Nasal Obstruction/Congestion Score	Treatment	30 Day	1.56	Standard Deviation 0.743	units on a scale
Nasal Obstruction/Congestion Score	Control	30 Day	1.79	Standard Deviation 0.674	units on a scale
Nasal Obstruction/Congestion Score	Treatment	Change from baseline	-0.80	Standard Deviation 0.729	units on a scale
Nasal Obstruction/Congestion Score	Control	Change from baseline	-0.56	Standard Deviation 0.619	units on a scale
Bilateral Polyp Grade	Treatment	Baseline	5.48	Standard Deviation 1.132	units on a scale
Bilateral Polyp Grade	Control	Baseline	5.43	Standard Deviation 1.009	units on a scale
Bilateral Polyp Grade	Treatment	Day 90	4.91	Standard Deviation 1.432	units on a scale
Bilateral Polyp Grade	Control	Day 90	5.26	Standard Deviation 1.378	units on a scale

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	S8 Sinus Implant	201
Overall Study	STARTED	Control	99
Overall Study	COMPLETED	S8 Sinus Implant	200
Overall Study	COMPLETED	Control	98
Overall Study	NOT COMPLETED	S8 Sinus Implant	1
Overall Study	NOT COMPLETED	Control	1

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Acute Sinusitis	Infections and infestations	Treatment	22	201
other	Acute Sinusitis	Infections and infestations	Control	12	99
other	Chronic Sinusitis	Infections and infestations	Treatment	10	201
other	Chronic Sinusitis	Infections and infestations	Control	8	99
other	Upper respiratory tract infection	Infections and infestations	Treatment	11	201
other	Upper respiratory tract infection	Infections and infestations	Control	4	99
other	Asthma	Respiratory, thoracic and mediastinal disorders	Treatment	10	201
other	Asthma	Respiratory, thoracic and mediastinal disorders	Control	4	99
serious	Epistaxis	Respiratory, thoracic and mediastinal disorders	Treatment	1	201	1
serious	Epistaxis	Respiratory, thoracic and mediastinal disorders	Control	0	99	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	0	201
Total, all-cause mortality	Control	0	99
Total, other adverse events	Treatment	53	201
Total, other adverse events	Control	28	99
Total, serious adverse events	Treatment	1	201
Total, serious adverse events	Control	0	99

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29350840	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment vs Control: deaths from any cause	Trial comparisons
Treatment vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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