NCT05486299

Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery

Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.

Detailed description

Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.

Conditions

• General Surgery

Interventions

Type	Name	Description
PROCEDURE	Robotic assisted single-port general surgery	Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-08-03
• Last updated: 2022-08-05

Locations

1 site across 1 country: China