Who is sponsoring NCT01894503?

NCT01894503 is sponsored by Intersect ENT.

What drugs are being tested in NCT01894503?

Interventions in NCT01894503: S8 Sinus Implant (mometasone furoate, 1350 mcg).

What condition does NCT01894503 study?

NCT01894503 studies Chronic Sinusitis.

Is NCT01894503 still recruiting?

NCT01894503 is currently completed. Last updated 22 June 2018.

Are results published for NCT01894503?

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

Last reviewed 2018-06-22 · How we verify

NCT01894503: S8PK

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

A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps

Completed Phase 2 Results posted Last updated 22 June 2018

What this trial tests

Phase 2 trial testing S8 Sinus Implant (mometasone furoate, 1350 mcg) in Chronic Sinusitis in 5 participants. Completed in 1 October 2013.

Timeline

1 June 2013

Primary endpoint
1 October 2013

1 October 2013

Quick facts

Lead sponsor	Intersect ENT
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 June 2013
Primary completion	1 October 2013
Estimated completion	1 October 2013
Sites	1 location across United States

Drugs / interventions tested

S8 Sinus Implant (mometasone furoate, 1350 mcg) — full drug profile →

Conditions studied

Chronic Sinusitis — all drugs for Chronic Sinusitis →

Sponsor

Intersect ENT — full company profile →

Who can join

18 and older, any sex, with Chronic Sinusitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Sinuses With Successful Implant Delivery
Time frame: End of baseline procedure
Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure

Sponsor's own description

The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Intersect ENT trials

Trials by the same sponsor.

NCT04858802 — A Clinical Evaluation of PROPEL® Contour Sinus Implant · NA · completed
NCT03599271 — A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND) · completed
NCT03358329 — Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) · Phase 3 · completed

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 NCT01894503 (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 Intersect ENT
Last refreshed: 22 June 2018

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/NCT01894503.

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