NCT06671639 Stanford Program to Accelerate Robotic Children's Surgery
| NCT ID | NCT06671639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Sleeve Gastrectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-08-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671639 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 21 Years, studying Sleeve Gastrectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671639 currently recruiting?
Yes, NCT06671639 is actively recruiting participants. Contact the research team at kbala@stanford.edu for enrollment information.
Where is the NCT06671639 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT06671639 clinical trial?
NCT06671639 is sponsored by Stanford University. The trial plans to enroll 250 participants.