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Salt Lake mask system

Phase 2

Obstructive Sleep Apnea | Unknown | Other |ResMed Inc.|Last Updated: Apr 20, 2012

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01395693Performance of the Salt Lake Mask SystemPHASE2 COMPLETED 20Jun 1, 2011Jul 1, 2011Apr 20, 20121 Australia
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Study Endpoints
Primary Endpoints
Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.
1 week

Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.

Secondary Endpoints
Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly
1 week
Subjectively Assessed Levels of Skin Markings
1 week
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Salt Lake mask systemEXPERIMENTAL -
Interventions
NameTypeDescription
Salt Lake mask systemDEVICEStudy participants will Salt Lake mask system for 1 week in place of their current mask system.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients willing to give written informed consent * Patients who can read and comprehend English * Patients using the Swift FX mask system * Patients who can trial the mask for 7 nights * Patients who have used PAP therapy for a minimum of 6 months. Exclusion Criteria: * Pat...

Countries:Australia
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