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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

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

da Vinci Sp Surgical System- Robotic · 1 trial · 1 indication

Phase 1 1
NCT02136121Prospective Investigation of Robotic Single-port SystemProstate and Kidney Cancer
COMPLETED19 Analytics
PHASE1COMPLETED
Prospective Investigation of Robotic Single-port System
Prostate and Kidney Cancer
NCT0213612119
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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 to 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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Frequently asked questions about da Vinci Sp Surgical System- Robotic

What is the da Vinci SP Surgical System used for?

The da Vinci SP Surgical System is a robotic surgical platform used for prostate and kidney cancer. It is designed to assist surgeons in performing minimally invasive procedures for these oncological conditions. The system is currently in clinical development and is not yet approved for general use.

Who makes the da Vinci SP Surgical System?

The da Vinci SP Surgical System is developed by Intuitive Surgical, Inc., a company traded on the NASDAQ under the ticker ISRG. Intuitive Surgical is the manufacturer of the da Vinci robotic surgical systems, and the SP model is one of their platforms being evaluated for use in prostate and kidney cancer procedures.

What phase is the da Vinci SP Surgical System in?

The da Vinci SP Surgical System is in Phase 1 clinical development. It is an investigational device, meaning it has not yet received regulatory approval and is still being studied for safety and feasibility. The Phase 1 trial for this system has been completed.

What clinical trials is the da Vinci SP Surgical System in?

The da Vinci SP Surgical System has one completed clinical trial registered as NCT02136121, titled 'Prospective Investigation of Robotic Single-port System.' This Phase 1 study enrolled 19 participants with prostate and kidney cancer in France. The trial was uncontrolled and not randomized or blinded.

Is the da Vinci SP Surgical System FDA approved?

The da Vinci SP Surgical System is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The completed trial, NCT02136121, was a Phase 1 study, and the system has not yet received marketing authorization from regulatory authorities.