Stanford Program to Accelerate Robotic Children's Surgery

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06671639
Status
Recruiting
Apply to this trial

Conditions

  • Bronchoplasty
  • Cervical and Thoracic Tracheoplasty
  • Cholecystectomy
  • Endolaryngeal Adjacent Tissue Transfer
  • Endometriosis
  • Endoscopic Laryngeal/Pharyngeal Suturing
  • Hysterectomy
  • Ileocolonic Resections
  • Laryngeal Cleft Repair
  • Laryngoplasty
  • Lobectomy/Wedge Lung Resection
  • Lung Segmentectomy
  • Pharyngoplasty
  • Proctectomy With Ileal Pouch-Anal Anastomosis
  • Sleeve Gastrectomy
  • Splenectomy
  • Thymectomy
  • Ureteral Re-implant
  • Vocal Feminization

Eligibility Criteria

Sex
ALL
Age
6 Years - 21 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Performance [ Time Frame: Intraoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital StanfordStanfordCalifornia94305
Grant Wells, MS
[email protected]
65-714-4344
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 (SUB_INVESTIGATOR)

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