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da Vinci Sp Surgical System - Robotic

Phase 1

Prostate and Kidney Cancer | Unknown | Oncology |Intuitive Surgical, Inc.|Last Updated: May 12, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02136121Prospective Investigation of Robotic Single-port SystemPHASE1 COMPLETED 19 — — Jun 1, 2010Oct 1, 2013May 12, 20141 France
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Study Endpoints
Primary Endpoints
To determine the feasibility as measured by the rate of conversions
Intra Operative

Rate of Conversion to Open approach

Secondary Endpoints
Perioperative surgical outcomes
From admission to discharge from the hospital for the primary procedure typically up to 7 days
Post-operative - Continence
1 year, 2 year and 3 year follow up
Perioperative Surgical Outcome- potency
1 , 2 and 3 year follow up
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
da Vinci Sp Surgical SystemEXPERIMENTALda Vinci Sp Surgical System - Robotic - assisted single-port surgery
Interventions
NameTypeDescription
da Vinci Sp Surgical System - RoboticDEVICErobotic assisted laparoscopic single-port system
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Prostatectomy: * Patients age 18-75 years * BMI \<=35 kg/m2 * Confirmed localized adenocarcinoma of the prostate * Suitable for minimally invasive prostate cancer surgery Nephrectomy: * Patient age 18-75 years * BMI \<=35 kg/m2 * Kidney disease amenable to nephrectomy or par...

Countries:France
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