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Stanford Program to Accelerate Robotic Children's Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

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

Locations
United States
California
Lucile Packard Children's Hospital Stanford
RECRUITING
Stanford
Contact Information
Primary
Karthik Balakrishnan, MD, MPH, FAAP, FACS
kbala@stanford.edu
(650) 724-4800
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 250
Treatments
Experimental: Arm 1
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
Experimental: Arm 2
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)
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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