NCT04526483

L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

Safety and Efficacy of a Novel Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in Laparoscopic Gastrectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Shanghai Minimally Invasive Surgery Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.

Detailed description

Background: Lymphadenectomy in laparoscopic gastrectomy can significantly improve the long-term survival and accuracy of the tumor staging of patients with gastric cancer. The retrieval of more lymph nodes has gradually become a trend among surgeons. However, lymphadenectomy is currently performed without the aid of visual instruments which might lead to an unknown pathological outcome and influence the prognosis of gastric cancer patients. And none of the indocyanine green (ICG) fluorescent imaging systems applied in clinical practice now is equipped with ultra-high definition (4K) or three-dimensional (3D) lens. To explore the advent of minimally invasive surgery with a conveniently switchable high-quality imaging system, we designed a new laparoscopic navigating technique that combined all the three characteristics. Aims: This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer. Methods/design This is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System on laparoscopic gastric surgery. The trial will recruit a total of 67 participants.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DEVICE	Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System	Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-08-25
• Last updated: 2020-08-25