Stanford Program to Accelerate Robotic Children's Surgery (NCT06671639) | Clinical Trial Compass
RecruitingNot Applicable
Stanford Program to Accelerate Robotic Children's Surgery
United States250 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
6 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance
Timeframe: Intraoperative
2
Number of Subjects With Device-related Serious Adverse Events
. 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