Stanford Program to Accelerate Robotic Children's Surgery
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 p
| Condition(s) | Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, Endometriosis, Ureteral Re-implant, Cervical and Thoracic Tracheoplasty, Thymectomy, Lobectomy/Wedge Lung Resection, Lung Segmentectomy, |
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| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Lead sponsor | Stanford University |
| Locations | Stanford, California, United States |
| Start date | 2025-08-01 |
| NCT ID | NCT06671639 |
| Official listing | https://clinicaltrials.gov/study/NCT06671639 |