Stanford Program to Accelerate Robotic Children's Surgery
Trial ID or NCT#
NCT06671639
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 6 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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 device4. Subject or their guardian is willing and able to provide written informed consent5. Subject or their guardian is willing and able to comply with the study protocol requirements
Exclusion Criteria:
- 1. Subject with uncorrected coagulopathy2. Subject has clinical requirement for primary open operative procedure3. Subject is ASA 4 or 5 status4. Subject is contraindicated for general anesthesia or surgery5. 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 consent6. Subject is pregnant or suspected to be pregnant
Investigator(s)
Steven D. Chang, MD
Neurosurgeon,
Aneurysm neurosurgeon,
Cerebrovascular neurosurgeon,
Pituitary tumors neurosurgeon,
Stereotactic neurosurgeon
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
Pediatric otolaryngologist,
Surgeon
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Michael Ma
Cardiothoracic surgeon
Associate Professor of Cardiothoracic Surgery (Pediatric Cardiac Surgery)
Natalie Shaubie Lui
Thoracic surgeon
Assistant Professor of Cardiothoracic Surgery (Thoracic Surgery)
Tulio Valdez, MD, MSc
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Kara Meister, MD, FAAP, FACS
Karthik Balakrishnan, MD, MPH, FAAP, FACS
Pediatric otolaryngologist
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Faraz A. Khan
Clinical Associate Professor, Surgery - Pediatric Surgery
Contact us to find out if this trial is right for you.
Contact
Grant Wells, MS
65-714-4344
View on ClinicalTrials.gov
