Who is sponsoring NCT03188822?

NCT03188822 is sponsored by University of Rochester.

What drugs are being tested in NCT03188822?

Interventions in NCT03188822: Bioabsorbable steroid releasing sinus implant, Bioabsorbable nasal dressing impregnated with steroid.

What condition does NCT03188822 study?

NCT03188822 studies Chronic Rhinosinusitis (Diagnosis).

Is NCT03188822 still recruiting?

NCT03188822 is currently terminated. Last updated 5 January 2023.

Are results published for NCT03188822?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-05 · How we verify

NCT03188822

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing

Terminated NA Results posted Last updated 5 January 2023

What this trial tests

NA trial testing Bioabsorbable steroid releasing sinus implant in Chronic Rhinosinusitis (Diagnosis) in 9 participants. Terminated before completion.

Timeline

25 August 2017

Primary endpoint
28 September 2021

2 November 2021

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	25 August 2017
Primary completion	28 September 2021
Estimated completion	2 November 2021
Sites	1 location across United States

Drugs / interventions tested

Bioabsorbable steroid releasing sinus implant
Bioabsorbable nasal dressing impregnated with steroid

Conditions studied

Chronic Rhinosinusitis (Diagnosis) — all drugs for Chronic Rhinosinusitis (Diagnosis) →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Chronic Rhinosinusitis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing Primary · 12 months

Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal

propel sinus stent frontal sinusotomy side is better

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

propel sinus stent frontal sinusotomy side is same

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	1

propel sinus stent frontal sinusotomy side is worse

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	1

Adhesion/Scarring Scale - Left Side Secondary · 12 months

Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement - Left side

adhesion/scarring Likert scale score of 0

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	3

adhesion/scarring Likert scale score of 1

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

Adhesion/Scarring Scale - Right Side Secondary · 12 months

Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement

adhesion/scarring Likert scale score of 0

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	2

adhesion/scarring Likert scale score of 1

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	1

Polypoid Edema Scale - Left Side Secondary · 12 months

Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement

polypoid edema Likert score 0

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 1

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 2

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 3

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 4

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	3

Polypoid Edema Scale - Right Side Secondary · 12 months

Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement

polypoid edema Likert score 0

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	1

polypoid edema Likert score 1

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 2

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 3

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0

polypoid edema Likert score 4

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	2

Frontal Sinus Opening Size Secondary · 12 months

Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid

Left

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	3

Right

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	1
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	2

Visualization of Frontal Sinus Roof Secondary · 12 months

Odds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	0
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	2

Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing Secondary · 30 Days

Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal

propel sinus stent frontal sinusotomy side is better

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	2

propel sinus stent frontal sinusotomy side is same

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	3

propel sinus stent frontal sinusotomy side is worse

Group	Value	95% CI
Bioabsorbable Steroid Releasing Sinus Implant & Nasal Dressing Impregnated With Steroid	3

Sponsor's own description

The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Chronic Rhinosinusitis (Diagnosis)

Currently open trials in the same condition.

NCT05427695 — Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis · Phase 2 · recruiting
NCT06986629 — Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusit · NA · recruiting
NCT05882903 — The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis · Phase 2 · recruiting
NCT05857228 — Viral and Epigenetic Influences in CRSwNP · active not recruiting
NCT04670172 — Real-Life Chronic Rhinosinusitis Outcome Registry · recruiting

Other University of Rochester trials

Trials by the same sponsor.

NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03188822 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Rochester
Last refreshed: 5 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188822.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing