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Clinical Trials/NCT00684684
NCT00684684CompletedPhase 1

A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy

Pulmonx Corporation1 site in 1 country18 target enrollmentStarted: May 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments during bronchoscopy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Intervention: Chartis System (Device)

Outcomes

Primary Outcomes

Adverse events

Time Frame: Until discharge or 24 hours post procedure

Secondary Outcomes

  • Technical success(During procedure)

Investigators

Sponsor Class
Industry

Study Sites (1)

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