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PINPOINT System

Phase 1

Biliary Anatomy | Unknown | Other |Stryker Corporation|Last Updated: Dec 2, 2014

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02070068A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic OperationsEARLY_PHASE1 COMPLETED 38Jan 1, 2014Nov 1, 2014Dec 2, 20141 United States
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Study Endpoints
Primary Endpoints
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)
10 minutes after injection
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALICG administered 10 minutes prior to time of visualization
Group 2EXPERIMENTALICG administered 45 min prior to time of visualization
Interventions
NameTypeDescription
PINPOINT SystemDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: To be eligible for the study, subjects must fulfill all of the following criteria: 1. Subjects who are healthy men or women 18 years of age or older. 2. Subjects who are scheduled for laparoscopic biliary or hepatic operations. 3. Subjects who sign an approved informed consent ...

Countries:United States
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