Stanford Program to Accelerate Robotic Children's Surgery

ConditionsSleeve Gastrectomy Cholecystectomy Splenectomy Hysterectomy Endometriosis Ureteral Re-implant Cervical and Thoracic Tracheoplasty Thymectomy Lobectomy/Wedge Lung Resection Lung Segmentectomy Bronchoplasty Endoscopic Laryngeal/Pharyngeal Suturing Vocal Feminization Laryngeal Cleft Repair Endolaryngeal Adjacent Tissue Transfer Pharyngoplasty Ileocolonic Resections Laryngoplasty Proctectomy With Ileal Pouch-Anal Anastomosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-21

SponsorStanford University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

da Vinci Xi Robotic Surgery System

Treatment groups

250 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

Source ClinicalTrials.gov