Actively Recruiting
Stanford Program to Accelerate Robotic Children's Surgery
Led by Stanford University · Updated on 2026-04-30
250
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Stanford Program to Accelerate Robotic Children's Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital Stanford
Stanford, California, United States, 94305
Actively Recruiting
Research Team
K
Karthik Balakrishnan, MD, MPH, FAAP, FACS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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