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Diagnostic CT, Diagnostic CT

Phase 3

Appendicitis | Unknown | Other |GE HealthCare Technologies Inc.|Last Updated: Sep 12, 2011

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment891
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00913380Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CTPHASE3 COMPLETED 891Sep 1, 2009Apr 1, 2011Sep 12, 20111 South Korea
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Study Endpoints
Primary Endpoints
Negative Appendectomy
1 week after surgery

Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)

Secondary Endpoints
Additional Imaging Test(s)
1 week after CT
Appendiceal Perforation
1 week after surgery
Interval Between CT and Appendectomy
1 day after surgery
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Low-dose CTEXPERIMENTAL -
Standard-dose CTACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Diagnostic CTRADIATION2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose))
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Eligibility Criteria
Age Range15 Years — 44 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Suspected of having acute appendicitis * Referred for abdomen CT from Emergency Department Exclusion Criteria: * Body mass index \< 18.5 kg/m2 (ultrasonography is favored) * Intravenous contrast-enhancement is contraindicated

Countries:South Korea
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