14 completed. 6 Not applicable, 5 Phase 3, 2 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 6 | Completed 6 |
| Phase 3 | 5 | Completed 5 |
| Phase 2 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Evaluation of PROPEL® Contour Sinus Implant PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone - Chronic Rhinosinusitis (Diagnosis) | Not applicable | Completed | Intersect ENT | 80 | 2021-05-12 | 2023-04-21 |
| A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND) Drug-Coated Device, Control Device - Chronic Rhinosinusitis (Diagnosis) | Completed | Intersect ENT | 75 | 2018-06-12 | 2021-05-26 | |
| Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) S8 Sinus Implant - Chronic Sinusitis, Nasal Polyposis | Phase 3 | Completed | Intersect ENT | 50 | 2017-11-13 | 2019-11-27 |
| In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone - Chronic Sinusitis | Not applicable | Completed | Intersect ENT | 50 | 2016-08-01 | 2018-12-10 |
| The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery Steroid-releasing sinus implant, Post-op standard of care - Chronic Sinusitis | Not applicable | Completed | ENT and Allergy Associates, LLP | 20 | 2015-12-01 | 2016-11-17 |
| The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant Steroid-eluting sinus implant, Post-op standard of care - Chronic Sinusitis, Ethmoidal | Phase 4 | Completed | Collin County Ear Nose & Throat | 40 | 2015-11-01 | 2018-10-12 |
| S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps S8 Sinus Implant, Mometasone furoate nasal spray, Sham - Chronic Sinusitis, Nasal Polyposis | Phase 3 | Completed | Intersect ENT | 300 | 2014-12-01 | 2018-08-15 |
| Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus PROPEL Mini Sinus Implant., Sinus Surgery alone, Propel Nova Sinus Implant - Chronic Sinusitis | Phase 3 | Completed | Intersect ENT | 160 | 2014-09-01 | 2018-08-15 |
| Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia Propel Nova Sinus Implant - Chronic Sinusitis | Not applicable | Completed | Intersect ENT | 15 | 2014-06-01 | 2017-08-04 |
| Safety and Performance of the Steroid-Releasing S8 Sinus Implant S8 Sinus Implant (mometasone furoate, 1350 mcg) - Chronic Sinusitis | Phase 2 | Completed | Intersect ENT | 5 | 2013-06-01 | 2018-07-18 |
| Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps S8 Sinus Implant, Sham procedure, Mometasone furoate nasal spray - Chronic Sinusitis, Nasal Polyps | Phase 2 / Phase 3 | Completed | Intersect ENT | 100 | 2013-01-01 | 2018-07-20 |
| A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis Sinus Stent with drug coating, Non Coated Sinus Stent - Chronic Sinusitis | Phase 3 | Completed | Intersect ENT | 105 | 2009-12-01 | 2015-06-22 |
| Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis Steroid-Eluting Sinexus Intranasal Splint - Chronic Sinusitis | Not applicable | Completed | Intersect ENT | 50 | 2009-03-01 | 2015-04-20 |
| A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis non-coated Intranasal Splint, Sinexus Intranasal Splint - Chronic Sinusitis | Not applicable | Completed | Intersect ENT | 50 | 2008-03-01 | 2020-10-01 |
Nasal Polyps (3) · Disease (2)
Mometasone Furoate (4) · Debridement (2) · Steroids (2) · Therapeutic Irrigation (2) · salicylhydroxamic acid (1)
United States (14)
Amber U. Luong, MD, PhD (1) · B.Todd Schaeffer, MD (1) · Bradley Marple, MD (1) · Brent Lanier, MD (1) · Jose P. Stolovitzky, MD (1) · Joseph K Han, MD (1) · Keith D Forwith, MD (1) · Keith E Matheny, MD (1) · Neil Bhattacharyya, MD (1) · Peter Manes, MD (1) · Randall Ow, MD (1) · Robert C Kern, MD (1) · Stacey Silvers (1) · Timothy L. Smith, MD, MPH (1) · William J. Brown, MD (1)