Trials / Not Yet Recruiting

Not Yet RecruitingNCT06671639

Stanford Program to Accelerate Robotic Children's Surgery

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 250 (estimated)

Sponsor: Stanford University · Academic / Other
Sex: All
Age: 6 Years – 21 Years
Healthy volunteers: Not accepted

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.

Detailed description

Advancements in robotic technology have facilitated the expansion of pediatric robotic surgery, enabling surgeons to perform increasingly complex procedures with greater precision and efficiency. Improved robotic platforms, enhanced imaging modalities, and innovative surgical techniques have contributed to the evolution of pediatric robotic surgery. Moreover, the development of specialized instruments and accessories tailored to pediatric patients, while in limited fashion, has further enhanced the safety and feasibility of robotic-assisted procedures in this population. The objective of this clinical study is to provide preliminary evidence showcasing that the da Vinci Xi Surgical System is substantially equivalent to existing surgical techniques for the performance of procedures that are the subject of this clinical study. The study will feature two sequential arms with a companion registry of non-robotic participants to compare outcomes and quality of life between each robotic approach and standard of care. The procedures included in each arm are: * Arm 1: Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, endometriosis, ureteral re-implant, and cervical and thoracic tracheoplasty, thymectomy, lobectomy/wedge lung resection, lung segmentectomy * Arm 2: 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) * Registry: The registry will recruit patients undergoing the procedures performed in Arm 1 and 2 who will be treated with current standard of care techniques instead of robotic surgery. Patient enrollment and assessments associated with procedures identified in Arm 1 will be completed prior to any procedures to be performed in Arm 2. The registry will prospectively enroll and evaluate patients undergoing non-surgical procedures at any time during the study period. Participants will be evaluated from the first pre-operative assessment to 7 weeks post-operative.

Conditions

Interventions

Type	Name	Description
DEVICE	da Vinci Xi Robotic Surgery System	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.

Timeline

Start date: 2025-03-01
Primary completion: 2027-02-28
Completion: 2028-02-28
First posted: 2024-11-04
Last updated: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06671639. Inclusion in this directory is not an endorsement.