Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sinuplasty · 1 trial · 1 indication
Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.
Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).
| Name | Type | Description |
|---|---|---|
| Sinuplasty | DEVICE | - |
Inclusion Criteria: 1. Age 18 years and greater 2. Both male and female patients eligible 3. Diagnosis of chronic sinusitis that is not responsive to medical management 4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient) Exclusion Criteria: 1. Extensive sinonasal poly...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Sinuplasty is used for chronic sinusitis, a condition involving inflammation of the paranasal sinuses. It is an investigational therapy being evaluated in clinical development for this ENT indication.
Sinuplasty is being developed by Integra LifeSciences Holdings Corporation, a company traded on the NASDAQ under the ticker IART.
Sinuplasty is in Phase 3 clinical development for chronic sinusitis. It is an investigational therapy and has not been approved by the FDA.
Sinuplasty has one completed Phase 3 clinical trial, identified as NCT00231062, titled "Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)." The trial enrolled 115 participants with chronic sinusitis.
The Phase 3 clinical trial for Sinuplasty, NCT00231062, was not randomized and did not use a control group. It was an uncontrolled study evaluating the safety and efficacy of the therapy in patients with chronic sinusitis.