Stanford Program to Accelerate Robotic Children's Surgery

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.

Conditions

• Sleeve 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

Interventions

DEVICE

da Vinci Xi Robotic Surgery System

The da Vinci Xi Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument and EndoWrist Xi instruments and accessories. The surgeon seated at the surgeon console controls all movement of the EndoWrist Xi instruments and Camera Instrument using two master controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a high-resolution stereo viewer (3D viewer), which provides him/her/they a view of patient anatomy and instrumentation, along with icons and other user interface features. The Vision Cart includes the supporting electronic and video processing equipment for the system.

Sponsors & Collaborators

• Stanford University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2027-02-28

Completion

2028-02-28

FDA Device

Yes

Countries

• United States

Study Locations