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Procedure
Arm 1 for Gallbladder Removal (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
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
No Placebo-Only Group
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.
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
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
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,496,282 Total Patients Enrolled
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