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PillCam

Phase 3

Colonic Diseases | Unknown | Other |Medtronic plc.|Last Updated: Jul 31, 2019

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 Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00951587Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night ProcedurePHASE3 COMPLETED 49Feb 1, 2008Mar 1, 2010Jul 31, 20192 Germany
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Study Endpoints
Primary Endpoints
Colon cleansing level score
within 7 days
Transit time in the different GI regions until excretion
within 7 days
Secondary Endpoints
Accuracy parameters of PCCE, compared to colonoscopy
within 7 days
Number of complete capsule procedure
within 7 days
Patient subjective assessment questionnaires
within 7 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPatients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.
Interventions
NameTypeDescription
PillCam™ (Capsule Endoscopy)DEVICEMedical Device
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR * Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOB...

Countries:Germany
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