NCT05566249

A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.

Conditions

• Rectal Cancer
• Rectosigmoid Cancer
• Rectosigmoid Junction Cancer

Interventions

Type	Name	Description
DEVICE	ArtiSential	Articulating laparoscopic instrument

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-31
• Completion: 2029-12-31
• First posted: 2022-10-04
• Last updated: 2022-10-06

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study