Stanford Program to Accelerate Robotic Children's Surgery
Stanford University
Summary
The goal of this clinical trial is to provide additional data to confirm safety and performance of the da Vinci Xi Surgical System in a human clinical setting. This pilot study is intended to provide an initial assessment to evaluate the feasibility, safety, and effectiveness for the utilization of the da Vinci Xi on pediatric and adolescent patients. This clinical trial will be conducted under the auspices of Stanford University's IRB approval.
Description
Advancements in robotic technology have facilitated the expansion of pediatric robotic surgery, enabling surgeons to perform increasingly complex procedures with greater precision and efficiency. Improved robotic platforms, enhanced imaging modalities, and innovative surgical techniques have contributed to the evolution of pediatric robotic surgery. Moreover, the development of specialized instruments and accessories tailored to pediatric patients, while in limited fashion, has further enhanced the safety and feasibility of robotic-assisted procedures in this population. The objective of this…
Eligibility
- Age range
- 6–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is between 6 - 21 years of age (weighing at least 15 kilograms) 2. Subject clinically diagnosed with a medical condition for which one of the study procedures is appropriate therapy and selected as the treatment of choice by the guardian and surgeon. 3. Subject without previous treatment using a robotic surgery device 4. Subject or their guardian is willing and able to provide written informed consent 5. Subject or their guardian is willing and able to comply with the study protocol requirements Exclusion Criteria: 1. Subject with uncorrected coagulopathy 2. S…
Interventions
- Deviceda Vinci Xi Robotic Surgery System
The da Vinci Xi Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument and EndoWrist Xi instruments and accessories. The surgeon seated at the surgeon console controls all movement of the EndoWrist Xi instruments and Camera Instrument using two master controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a high-resolution stereo viewer (3D viewer), which provides him/her/they a view of patient anatomy and instrumentation, along with icons and other user interface features. The Vision Cart includes the supporting electronic and video processing equipment for the system.
Location
- Lucile Packard Children's Hospital StanfordStanford, California