Trials / Completed
CompletedNCT03358329
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study: Safety Evaluation of Repeat Placement of the Corticosteroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Intersect ENT · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The ENCORE Study is a prospective open-label, non-randomized, multicenter study in CS patients who had undergone prior endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy and present with bilateral ethmoid polyposis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | S8 Sinus Implant | In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses |
Timeline
- Start date
- 2017-11-13
- Primary completion
- 2019-01-17
- Completion
- 2019-01-17
- First posted
- 2017-11-30
- Last updated
- 2019-11-27
- Results posted
- 2019-11-27
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03358329. Inclusion in this directory is not an endorsement.