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Stanford Program to Accelerate Robotic Children's Surgery
Who can join
Ages 6 to 21 · All sexes
Full eligibility criteria
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. Subject has clinical requirement for primary open operative procedure 3. Subject is ASA 4 or 5 status 4. Subject is contraindicated for general anesthesia or surgery 5. 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 6. Subject is pregnant or suspected to be pregnant
About the study
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.
What is being tested
- da Vinci Xi Robotic Surgery System (device)
Sponsor: Stanford University · Participants: 250 · Started: Aug 1, 2025
Contact the study team
- Karthik Balakrishnan, MD, MPH, FAAP, FACS · Phone: (650) 724-4800
Official record on ClinicalTrials.gov — NCT06671639
Locations in the U.S.
| California | Lucile Packard Children's Hospital Stanford, Stanford |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.