CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
S8 Sinus Implantcombination
Likely dose
Mometasone furoate 1350 mcg via bilateral S8 Sinus Implant in-office placementAI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Confirmed diagnosis of chronic sinusitis with nasal polyps per 2016 International Consensus Statement on Allergy and Rhinology
  • ✓Prior bilateral total ethmoidectomy at least 90 days before screening
  • ✓Bilateral ethmoid sinus obstruction due to polyps (grade ≥2 on each side)
Key exclusion· 15
  • ✕Extensive ethmoid sinus polyp grade (grade 4 on at least one side)
  • ✕Extensive adhesions/synechiae (grade 3 or 4)
  • ✕Parenteral or injected steroids (e.g., Kenalog) within 30 days of baseline procedure
  • ✕Oral steroids, budesonide, sinus steroid irrigations/rinses, nebulized steroids, or budesonide drops within 14 days of baseline procedure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03358329
NCT03358329Phase 3Completed
CompareCT.gov

The ENCORE Study: Safety Evaluation of Repeat Placement of the Corticosteroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps

Intersect ENT·interventional·Posted Nov 30, 2017·Updated Nov 27, 2019

In Brief

A Phase 3 clinical trial evaluating S8 Sinus Implant for Chronic Sinusitis and Nasal Polyposis. Completed, enrolled 50 participants across 9 sites.

Detailed Summary

The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis, Nasal Polyposis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 30, 2017
Enrollment StartNov 13, 2017
Primary CompletionJan 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.6 years ago

Interventions

S8 Sinus Implantcombination

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses