Stanford Program to Accelerate Robotic Children's Surgery
Recruiting · NCT06671639 · Interventional (participants receive a specific treatment) · Lead sponsor: Stanford University
View the official record on ClinicalTrials.gov →Interventions studied
da Vinci Xi Robotic Surgery System
What this trial is about
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.
Who can take part
Age range
6 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Subject is between 6 - 21 years of age (weighing at least 15 kilograms)
- 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.
- Subject without previous treatment using a robotic surgery device
- Subject or their guardian is willing and able to provide written informed consent
- Subject or their guardian is willing and able to comply with the study protocol requirements
Exclusion criteria
- Subject with uncorrected coagulopathy
- Subject has clinical requirement for primary open operative procedure
- Subject is ASA 4 or 5 status
- Subject is contraindicated for general anesthesia or surgery
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject is pregnant or suspected to be pregnant
Where it is running
1 location listed across 1 US state.
- Lucile Packard Children's Hospital Stanford - Stanford, California, United States