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 range6 Years – 21 Years

SexALL

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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

What they're measuring

Performance

Timeframe: Intraoperative

Number of Subjects With Device-related Serious Adverse Events

Timeframe: Intraoperative

Trial details

NCT IDNCT06671639

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

Karthik Balakrishnan, MD, MPH, FAAP, FACS

(650) 724-4800 kbala@stanford.edu

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