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

NCT06562179 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-08-20

No results posted yet for this study

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.

Conditions

  • Hepatopancreaticobiliary and Foregut Operations

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.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Sharona Ross, MD · AdventHealth

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2025-06-30
Completion
2030-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562179 on ClinicalTrials.gov