Stanford Program to Accelerate Robotic Children's Surgery

NCT06671639 | Recruiting DMC FDA Device

• 1 other identifier: 78052
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Robotic Surgery; Pediatric Robotic Surgery

Outcome Measures

Primary Outcomes (2)

• Performance

  Performance defined as the conversion to an open approach required to complete the procedure

  Intraoperative

• Number of Subjects With Device-related Serious Adverse Events

  Safety is determined by measuring the number of subjects that experience device-related serious adverse events

  Intraoperative

Secondary Outcomes (1)

• Pediatric Quality of Life Inventory (PedsQL) score

  From enrollment to the end of treatment follow-up at 7 weeks post-operative

Study Arms (2)

Arm 1

EXPERIMENTAL

Arm 1 includes procedures to be performed robotically that have an adult model or already established preclinical evidence including: Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, endometriosis, ureteral re-implant, and cervical and thoracic tracheoplasty, thymectomy, lobectomy/wedge lung resection, lung segmentectomy

Device: da Vinci Xi Robotic Surgery System

Arm 2

EXPERIMENTAL

Arm 2 will be performed after all patients in Arm 1 have completed their procedures and where additional preclinical performance testing is required, including: Bronchoplasty, Endoscopic Laryngeal/Pharyngeal Suturing, including: Vocal Feminization, Laryngeal Cleft Repair, Endolaryngeal Adjacent Tissue Transfer, Pharyngoplasty; Ileocolonic Resections; Laryngoplasty with or without Graft; Proctectomy with Ileal Pouch-Anal Anastomosis (IPAA)

Device: da Vinci Xi Robotic Surgery System

Interventions

da Vinci Xi Robotic Surgery System DEVICE

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Subject or their guardian is willing and able to comply with the study protocol requirements

You may not qualify if:

• 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
• 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
• Subject is pregnant or suspected to be pregnant

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Karthik Balakrishnan, MD, MPH, FAAP, FACS

CONTACT

(650) 724-4800; kbala@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head & Neck Surgery

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)