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

Description

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.

Conditions

Hepatopancreaticobiliary and Foregut Operations

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hepatopancreaticobiliary and Foregut Operations
Intervention / Treatment

-

Contacts and Locations

Tampa

AdventhHealth, Tampa, Florida, United States, 33613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Subject requiring an emergent operation
  • * Pregnancy or nursing
  • * BMI \> 26 kg/m2
  • * Previous abdominal surgery
  • * Subjects with malignant disease
  • * Inability to provide informed consent
  • * Contraindicated for general anesthesia or minimally invasive surgery

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AdventHealth,

Sharona Ross, MD, PRINCIPAL_INVESTIGATOR, AdventHealth

Study Record Dates

2030-06