Stanford Program to Accelerate Robotic Children's Surgery (SPARCS)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Hysterectomy; Cholecystectomy; Sleeve Gastrectomy; Splenectomy; Thymectomy; Ureteral Re-implant; Cervical and Thoracic Tracheoplasty; Lung Segmentectomy; Bronchoplasty; Endoscopic Laryngeal/Pharyngeal Suturing; Vocal Feminization; Laryngeal Cleft Repair; Endolaryngeal Adjacent Tissue Transfer; Pharyngoplasty; Ileocolonic Resections; Laryngoplasty; Lobectomy/Wedge Lung Resection; Proctectomy With Ileal Pouch-Anal Anastomosis
• Intervention / Treatment: Device: da Vinci Xi Robotic Surgery System

Detailed Description

Advancements in robotic technology have facilitated the expansion of pediatric robotic surgery, enabling surgeons to perform increasingly complex procedures with greater precision and efficiency. Improved robotic platforms, enhanced imaging modalities, and innovative surgical techniques have contributed to the evolution of pediatric robotic surgery. Moreover, the development of specialized instruments and accessories tailored to pediatric patients, while in limited fashion, has further enhanced the safety and feasibility of robotic-assisted procedures in this population.

The objective of this clinical study is to provide preliminary evidence showcasing that the da Vinci Xi Surgical System is substantially equivalent to existing surgical techniques for the performance of procedures that are the subject of this clinical study. The study will feature two sequential arms with a companion registry of non-robotic participants to compare outcomes and quality of life between each robotic approach and standard of care. The procedures included in each arm are:

• Arm 1: Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, endometriosis, ureteral re-implant, and cervical and thoracic tracheoplasty, thymectomy, lobectomy/wedge lung resection, lung segmentectomy
• Arm 2: 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)
• Registry: The registry will recruit patients undergoing the procedures performed in Arm 1 and 2 who will be treated with current standard of care techniques instead of robotic surgery.

Patient enrollment and assessments associated with procedures identified in Arm 1 will be completed prior to any procedures to be performed in Arm 2. The registry will prospectively enroll and evaluate patients undergoing non-surgical procedures at any time during the study period.

Participants will be evaluated from the first pre-operative assessment to 7 weeks post-operative.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karthik Balakrishnan, MD, MPH, FAAP, FACS; Phone Number: (650) 724-4800; Email: kbala@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Lucile Packard Children's Hospital Stanford
      • Contact: Grant Wells, MS; Phone Number: 65-714-4344; Email: gwells2@stanford.edu
      • Sub-Investigator: Natalie Lui, MD, MAS
      • Sub-Investigator: Brian Nuyen, MD
      • Sub-Investigator: Faraz Khan, MD
      • Sub-Investigator: Janey S.A. Pratt, MD
      • Sub-Investigator: Nichole Tyson, MD
      • Sub-Investigator: Stephanie Cizek, MD
      • Sub-Investigator: Douglas Sidell, MD
      • Sub-Investigator: Tulio Valdez, MD, MSc
      • Sub-Investigator: Kara Meister, MD, FAAP, FACS
      • Sub-Investigator: Daniel Han, MD
      • Sub-Investigator: Kunj Sheth, MD
      • Sub-Investigator: Michael Ma, MD
      • Sub-Investigator: Erin Grantham, MD
      • Sub-Investigator: Patrick Kiessling, MD
      • Sub-Investigator: Carolyn Chang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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; 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.
Experimental: Arm 2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory (PedsQL) score	Score of questionnaire	From enrollment to the end of treatment follow-up at 7 weeks post-operative

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Surgery; Pediatric Robotic Surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 78052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No