NCT02228720

Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.

Detailed description

This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	Propel Nova Sinus Implant	Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-10-01
• Completion: 2015-01-01
• First posted: 2014-08-29
• Last updated: 2017-08-04
• Results posted: 2017-08-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study