Stanford program to advance robotic surgery for children and adolescents
Official title: Stanford Program to Accelerate Robotic Children's Surgery
Run by Stanford University · NCT06671639 · Data updated 2026-11-12
This program will try the da Vinci Xi surgical robot in children and adolescents (ages 6–21, ≥15 kg) to see if it is safe and works well for procedures like sleeve gastrectomy, cholecystectomy, splenectomy, hysterectomy, and operations for endometriosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 21 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT06671639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 6–21 (weighing ≥15 kg) who need one of the listed procedures, whose surgeon and guardian choose the robotic approach, can provide informed consent, and meet safety criteria are ideal candidates.
✕Probably not a fit
Patients who require a primary open operation, have uncorrected coagulopathy, are ASA class 4–5, are pregnant, or cannot tolerate general anesthesia are unlikely to receive benefit from the robotic approach in this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot interventional program at Lucile Packard Children’s Hospital Stanford will collect initial human data on the safety and performance of the da Vinci Xi Surgical System in pediatric and adolescent patients. The study enrolls patients aged 6–21 (weighing at least 15 kg) who are undergoing specified procedures and have not previously had robotic surgery. It uses two sequential robotic arms plus a companion registry of non-robotic (standard of care) participants to compare outcomes and quality of life between robotic approaches and conventional surgery. All procedures and follow-up will be conducted under Stanford IRB oversight to document feasibility, safety, and effectiveness.
Why it matters
Potential benefit: If successful, the robotic system could enable more precise minimally invasive operations with smaller incisions, less blood loss, and potentially faster recovery for pediatric patients.
How similar studies have gone: Prior case series and smaller studies have demonstrated feasibility and favorable outcomes for pediatric robotic procedures, but large comparative data specifically for the da Vinci Xi in children remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Lucile Packard Children's Hospital Stanford
Stanford, California, United States Recruiting
Study contacts
- Study coordinator: Karthik Balakrishnan, MD, MPH, FAAP, FACS
- Email: kbala@stanford.edu
- Phone: (650) 724-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.