Robotic Surgery for Pediatric Procedures

(SPARCS Trial)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for pediatric and adolescent patients needing surgeries like gallbladder removal, hysterectomy, or lung surgery. It's not specified who can't join the trial, but typically those with conditions that could complicate surgery or recovery might be excluded.

Inclusion Criteria

Subject or their guardian is willing and able to provide written informed consent

Subject or their guardian is willing and able to comply with the study protocol requirements

My doctor and I have chosen a study procedure as the best treatment for my condition.

Exclusion Criteria

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

I have a bleeding disorder that hasn't been treated.

I need surgery as my main treatment.

Treatment Details

Interventions

• da Vinci Xi Robotic Surgery System (Procedure)

Trial Overview The da Vinci Xi Robotic Surgery System is being tested to see if it's safe and works well for various surgeries in young patients. This pilot study by Stanford University will initially assess its feasibility and effectiveness.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

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)

Group II: Arm 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD