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Sinuplasty

Phase 3

Chronic Sinusitis | Unknown | ENT |Integra LifeSciences Holdings Corporation|Last Updated: Aug 6, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment115
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00231062Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)PHASE3 COMPLETED 115Apr 1, 2005Jun 1, 2006Aug 6, 2024 -
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Study Endpoints
Primary Endpoints
Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
24 weeks

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.

Number of Participants With Adverse Events Following Sinuplasty Procedure
24 weeks

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).

Secondary Endpoints
Number of Participants Experiencing Relief of Sinus Symptoms
Week 24
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SinuplastyDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

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...

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Competitive Landscape -Chronic Rhinosinusitis 12 trials