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

ConditionHepatopancreaticobiliary and Foregut Operations

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorAdventHealth

About this trial

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 criteria

Qualifiers

Patients between the ages of 18 and 80 years of age

Either male or female

BMI ≤ 26 kg/m2

ASA ≤ 3

Disqualifiers

Subject requiring an emergent operation

Pregnancy or nursing

BMI > 26 kg/m2

Previous abdominal surgery

Trial design

Treatments tested in this trial

da Vinci SP® Single-Port Robotic Surgical System

Treatment groups

35 Participants

are divided into 1 treatment group

Sponsors and collaborators

AdventHealth

Lead sponsor

Source ClinicalTrials.gov