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Procedure

Robotic Surgery for Pediatric Procedures (SPARCS Trial)

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is between 6 - 21 years of age (weighing at least 15 kilograms)

Subject without previous treatment using a robotic surgery device

Must not have

Subject with uncorrected coagulopathy

Subject has clinical requirement for primary open operative procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to gather more information to ensure that the da Vinci Xi Surgical System is safe and works well when used on pediatric and adolescent patients. It will be a small study to see if the system

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, robotic surgeries may involve risks such as bleeding, infection, or complications related to anesthesia similar to traditional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 21 years old and weigh at least 15 kilograms.

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I have never been treated with robotic surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need surgery as my main treatment.

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I cannot undergo surgery or general anesthesia due to health risks.

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I am in a very severe state of health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Subjects With Device-related Serious Adverse Events

Performance

Secondary study objectives

Pediatric Quality of Life Inventory (PedsQL) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 6Eligibility criteria met