Stanford Program to Accelerate Robotic Children's Surgery

Launched by STANFORD UNIVERSITY · Oct 31, 2024

Keywords

ClinConnect Summary

The Stanford Program to Accelerate Robotic Children's Surgery is a clinical trial aimed at testing the safety and effectiveness of a special robotic surgical system called the da Vinci Xi. This study will look specifically at how well this technology works for treating various medical conditions in children and young adults aged 6 to 21. Some of the conditions being studied include surgeries for obesity, gallbladder removal, endometriosis, and several other complex procedures. The trial is not yet recruiting participants, but it will be conducted with careful approval from Stanford University's ethics board.

To be eligible for the trial, participants must be between 6 and 21 years old, weigh at least 15 kilograms, and have a medical condition that requires one of the surgeries being studied. They also should not have had any previous robotic surgery. Participants and their guardians will need to agree to the study's rules and provide written consent. Throughout the trial, participants can expect close monitoring and support from the medical team to ensure safety and gather important information about the robotic system's performance in young patients.

Gender

ALL

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