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250 Participants Needed

Robotic Surgery for Pediatric Procedures
(SPARCS Trial)

Overseen ByKarthik Balakrishnan, MD, MPH, FAAP, FACS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Coagulopathy, ASA 4 or 5, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment da Vinci Xi Robotic Surgery System for pediatric procedures?

Research shows that the da Vinci Xi system has been successfully used in various surgeries, including pediatric ones, by improving the ability to perform minimally invasive procedures. It has been designed to overcome limitations of previous systems, making it safer and more feasible for complex surgeries.¹ ² ³ ⁴ ⁵

Is robotic surgery safe for children?

Research shows that robotic surgery, including the da Vinci system, has been used safely in pediatric procedures, especially in urology, with studies assessing its safety and feasibility. While there are some complications reported, these are analyzed to improve safety in future procedures.³ ⁴ ⁵ ⁶ ⁷

How is the da Vinci Xi Robotic Surgery System different from other treatments for pediatric procedures?

The da Vinci Xi Robotic Surgery System is unique because it allows for precise, minimally invasive surgery using robotic technology, which can be especially beneficial in complex pediatric procedures. This system is designed to overcome limitations of previous robotic systems, enabling more versatile and multiquadrant surgeries, which can lead to better outcomes and quicker recovery times for children.³ ⁴ ⁵ ⁶ ⁸

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.

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.

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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.

See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments to prepare for robotic surgery

1-2 weeks

Treatment - Arm 1

Participants undergo robotic surgery for procedures such as Sleeve Gastrectomy, Cholecystectomy, and others

Variable, based on procedure

Treatment - Arm 2

Participants undergo additional robotic surgeries after Arm 1 completion, including Bronchoplasty and other procedures

Variable, based on procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

7 weeks post-operative

Treatment Details

Interventions

da Vinci Xi Robotic Surgery System

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

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 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 1Experimental Treatment1 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