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Chartis System

Phase 1

Bronchoscopy | Unknown | Other |Pulmonx Corporation|Last Updated: Jan 22, 2009

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00684684Safety and Feasibility Study of the Chartis SystemPHASE1 COMPLETED 18May 1, 2008Nov 1, 2008Jan 22, 20091 Germany
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Study Endpoints
Primary Endpoints
Adverse events
Until discharge or 24 hours post procedure
Secondary Endpoints
Technical success
During procedure
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
Chartis SystemDEVICEAssessment of airway flow and pressure
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Scheduled to undergo clinically indicated routine diagnostic bronchoscopy Exclusion Criteria: * Hyperexcretive chronic bronchitis or excessive sputum secretion * Active pulmonary infection * FEV1 \<20% predicted * FVC \<50% predicted

Countries:Germany
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