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Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

NCT06362070 · Azienda Ospedaliera Universitaria Integrata Verona · Updated 12 April 2024

What is being tested
DaVinci® Surgical System; Hugo™ RAS System; Versius® Robotic Surgery System
For
Gastric Cancer; Gastrointestinal Cancer; Neoplasms; Gastric Diffuse Adenocarcinoma; Gastric Neoplasm; Stomach Adenocarcinoma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 75 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 31 Jan 2024, ends 31 July 2025. Registered 12 April 2024.
Results
None posted yet.

In the researchers' words

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms: * DaVinci; * Hugo; * Versius. This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one. The questions it aims to answer are: * Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable? * Are there any differences between the three platforms related to the learning curve for surgeons? Participants will be enrolled, after obtaining informed consent, in one of the following cohorts: 1. surgery with the daVinci platform; 2. surgery with the Hugo platform; 3. surgery with the Versius platform.
ClinicalTrials.gov, NCT06362070

Sites

  • General and Upper GI UnitVerona, Italy