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Stanford Program to Accelerate Robotic Children's Surgery
Not Recruiting
Trial ID: NCT06671639
Purpose
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.
Official Title
Stanford Program to Accelerate Robotic Children's Surgery
Stanford Investigator(s)
Steven D. Chang, MD
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology and Neurological Sciences
Douglas Sidell, MD
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Michael Ma
Associate Professor of Cardiothoracic Surgery (Pediatric Cardiac Surgery)
Natalie Shaubie Lui
Assistant Professor of Cardiothoracic Surgery (Thoracic Surgery)
Tulio Valdez, MD, MSc
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Karthik Balakrishnan, MD, MPH, FAAP, FACS
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Faraz A. Khan
Clinical Associate Professor, Surgery - Pediatric Surgery
Eligibility
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
Intervention(s):
device: da Vinci Xi Robotic Surgery System
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Grant Wells, MS
65-714-4344