Trial · NCT01732536

Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

NCT01732536, Phase 2, Phase 3, Completed, Intersect ENT; results first posted 2018-07-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps. Trials, record NCT01732536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01732536

On this page

Trial

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

Title: Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
NCT number: NCT01732536
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 100 participants, actual
Lead sponsor: Intersect ENT
Conditions: Chronic Sinusitis, Nasal Polyps
Interventions: S8 Sinus Implant, Sham procedure, Mometasone furoate nasal spray
First posted: 2012-11-26
Last updated: 2018-07-20
Results first posted: 2018-07-20
Limitations and caveats: 1. Absence of defined medical regimen prior to enrollment~2. Investigators grading polyps and assessing indication for RESS were not blinded~3. Indication for RESS at baseline allowed for 1 sinus side to have polyp grade \>=1

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Nasal Obstruction/Congestion Score	90 days	Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in
Primary	Bilateral Polyp Grade	90 days	Polyp grade was determined by a panel of 3 independent 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 represented reduction (improvement) in bilateral polyp grade.
Secondary	Ethmoid Sinus Obstruction	90 days	Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent 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 represented reduction (improvement) in ethmoid sinus obstruction.
Secondary	Bilateral Polyp Grade	90 days, 6 months	Polyps were graded by clinical investigators on a scale 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 indicate reduction (improvement) in nasal polyps.
Secondary	Nasal Obstruction Symptom Evaluation (NOSE) Score	6 months	NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.
Secondary	Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)	90 days, 6 months	To be indicated for RESS, the following criteria had to be met: * Continued to use topical intranasal steroids daily; * Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use * Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and * Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade \>=2 on at least one side)

Source ClinicalTrials.gov

Outcomes6

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	90 days	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.	units on a scale	MEAN
PRIMARY	Bilateral Polyp Grade	90 days	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.	units on a scale	MEAN
SECONDARY	Ethmoid Sinus Obstruction	90 days	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Bilateral Polyp Grade	90 days, 6 months	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Nasal Obstruction Symptom Evaluation (NOSE) Score	6 months	Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.	units on a scale	MEAN
SECONDARY	Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)	90 days, 6 months	Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.	Participants	COUNT_OF_PARTICIPANTS

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	3.62	Standard Deviation 1.180	units on a scale
Nasal Obstruction/Congestion Score	Control	Baseline	3.30	Standard Deviation 1.159	units on a scale
Nasal Obstruction/Congestion Score	Treatment	Day 90	2.31	Standard Deviation 1.422	units on a scale
Nasal Obstruction/Congestion Score	Control	Day 90	2.62	Standard Deviation 1.336	units on a scale
Nasal Obstruction/Congestion Score	Treatment	Change from baseline	-1.33	Standard Deviation 1.465	units on a scale
Nasal Obstruction/Congestion Score	Control	Change from baseline	-0.67	Standard Deviation 1.446	units on a scale
Bilateral Polyp Grade	Treatment	Baseline	4.90	Standard Deviation 0.918	units on a scale
Bilateral Polyp Grade	Control	Baseline	4.39	Standard Deviation 1.448	units on a scale
Bilateral Polyp Grade	Treatment	Day 90	4.12	Standard Deviation 1.162	units on a scale
Bilateral Polyp Grade	Control	Day 90	4.00	Standard Deviation 1.720	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	Treatment	53
Overall Study	STARTED	Control	47
Overall Study	COMPLETED	Treatment	52
Overall Study	COMPLETED	Control	46
Overall Study	NOT COMPLETED	Treatment	1
Overall Study	NOT COMPLETED	Control	1

Source ClinicalTrials.gov

Adverse events18

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
other	Chronic Sinusitits	Infections and infestations	Treatment	11	53
other	Chronic Sinusitits	Infections and infestations	Control	14	47
other	Upper respiratory tract infection	Infections and infestations	Treatment	5	53
other	Upper respiratory tract infection	Infections and infestations	Control	2	47
other	Acute sinusitis	Infections and infestations	Treatment	8	53
other	Acute sinusitis	Infections and infestations	Control	11	47
other	Nasopharyngitis	Infections and infestations	Treatment	3	53
other	Nasopharyngitis	Infections and infestations	Control	3	47
other	Headache	Nervous system disorders	Treatment	3	53
other	Headache	Nervous system disorders	Control	2	47

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment	0	53
Total, all-cause mortality	Control	0	47
Total, other adverse events	Treatment	38	53
Total, other adverse events	Control	36	47
Total, serious adverse events	Treatment	0	53
Total, serious adverse events	Control	1	47

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25266981	BACKGROUND	PubMed
26992115	RESULT	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.

GET https://conductscience.org/api/trials/v1/NCT01732536

GET https://conductscience.org/api/trials/v1/NCT01732536/results?page=2

API reference For AI assistants