Actively Recruiting
Stanford Program to Accelerate Robotic Children's Surgery
Led by Stanford University · Updated on 2026-04-30
250
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, performance, and feasibility of the da Vinci Xi Surgical System in pediatric and adolescent patients undergoing various surgical procedures. The trial seeks to confirm that this robotic system is comparable to existing surgical methods. Conducted with Stanford University's IRB approval, the study includes children and young adults aged 6 to 21 years, focusing on a range of surgeries from sleeve gastrectomy to laryngoplasty. The study has two sequential groups: Arm 1 involves robotic surgeries with established adult models or prior preclinical support, including procedures like cholecystectomy and thoracic tracheoplasty. Arm 2, starting after Arm 1 completion, includes more complex surgeries such as bronchoplasty and proctectomy with ileal pouch-anal anastomosis. Additionally, there is a registry for patients receiving standard non-robotic care for comparison. Participants are monitored from pre-operative assessments through 7 weeks post-operation. Participants will undergo evaluations before and after surgery to assess outcomes like intraoperative performance and device-related adverse events. Quality of life will be measured using the Pediatric Quality of Life Inventory from enrollment until 7 weeks after surgery. The study is non-randomized and unblinded, and aims to gather comprehensive data on robotic surgery's impact in this young population.
CONDITIONS
Brief Title
Stanford Program to Accelerate Robotic Children's Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is between 6 and 21 years of age and weighs at least 15 kilograms
- Subject has a medical condition appropriate for one of the study procedures, as chosen by guardian and surgeon
- Subject has not previously had robotic surgery
- Subject or guardian is willing and able to provide written informed consent
- Subject or guardian is willing and able to follow the study protocol requirements
You will not qualify if you...
- Subject has uncorrected blood clotting problems (coagulopathy)
- Subject requires a primary open surgery instead of robotic surgery
- Subject has an ASA status of 4 or 5 (severe systemic disease)
- Subject cannot safely undergo general anesthesia or surgery
- Subject has mental handicap, psychological disorder, or severe illness preventing compliance or consent
- Subject is pregnant or suspected to be pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - From surgery day to discharge
Participants undergo robotic-assisted surgery using the da Vinci Xi Surgical System for various pediatric procedures.
1 surgical procedure visit
Duration - Up to 7 weeks post-operative
Participants are monitored for recovery and quality of life after robotic surgery.
Weekly visits for up to 7 weeks post-operative
Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital Stanford
Stanford, California, United States, 94305
Actively Recruiting
Research Team
K
Karthik Balakrishnan, MD, MPH, FAAP, FACS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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