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Stanford Program to Accelerate Robotic Children's Surgery

ConditionsSleeve GastrectomyCholecystectomySplenectomyHysterectomyEndometriosisUreteral Re-implantCervical and Thoracic TracheoplastyThymectomyLobectomy/Wedge Lung ResectionLung SegmentectomyBronchoplastyEndoscopic Laryngeal/Pharyngeal SuturingVocal FeminizationLaryngeal Cleft RepairEndolaryngeal Adjacent Tissue TransferPharyngoplastyIleocolonic ResectionsLaryngoplastyProctectomy With Ileal Pouch-Anal Anastomosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-21
SponsorStanford University

About 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 does not accept healthy volunteers

Qualifiers

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

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.

Subject without previous treatment using a robotic surgery device

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

Disqualifiers

Subject with uncorrected coagulopathy

Subject has clinical requirement for primary open operative procedure

Subject is ASA 4 or 5 status

Subject is contraindicated for general anesthesia or surgery

Trial design

Design model

Single group

Treatments tested in this trial

  • da Vinci Xi Robotic Surgery System

    Device

    The da Vinci Xi Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument and EndoWrist Xi instruments and accessories. The surgeon seated at the surgeon console controls all movement of the EndoWrist Xi instruments and Camera Instrument using two master controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a high-resolution stereo viewer (3D viewer), which provides him/her/they a view of patient anatomy and instrumentation, along with icons and other user interface features. The Vision Cart includes the supporting electronic and video processing equipment for the system.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Performance

Performance defined as the conversion to an open approach required to complete the procedure

Time frame
Intraoperative
2

Number of Subjects With Device-related Serious Adverse Events

Safety is determined by measuring the number of subjects that experience device-related serious adverse events

Time frame
Intraoperative

Secondary outcomes

1

Pediatric Quality of Life Inventory (PedsQL) score

Score of questionnaire

Time frame
From enrollment to the end of treatment follow-up at 7 weeks post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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