Recruiting

da Vinci Xi

Sponsor:

Stanford University

Code:

NCT06671639

Conditions

Sleeve Gastrectomy

Cholecystectomy

Splenectomy

Hysterectomy

Endometriosis

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

da Vinci Xi Robotic Surgery System

Study Details

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

Study ID

NCT06671639

Start date

Aug 1, 2025

Status verified date

Apr, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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)

Interventions

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.

Primary outcome measure

  • Performance [ Time Frame: Intraoperative ]
  • Number of Subjects With Device-related Serious Adverse Events [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Karthik Balakrishnan, MD, MPH, FAAP, FACS

(650) 724-4800kbala@stanford.edu

Locations

Lucile Packard Children's Hospital Stanford

Recruiting

Stanford, California, United States, 94305

Contacts

Grant Wells, MS

65-714-4344gwells2@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Robotic Surgery
  • Pediatric Robotic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-30.