A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.

AdventHealth

Summary

The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria Cholecystectomy Stage 1 - Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either male or female * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign disease Fundoplication Stage 1- Inclusion Criteria: * Patients diagnosed with GERD and/or hiatal hernia * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 Gastrectomy Stage 2- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or relatively early malig…

Interventions

Device
da Vinci SP® Single-Port Robotic Surgical System
The da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

Location

AdventhHealth
Tampa, Florida
danel.robledo@adventhealth.com 8139716000

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions