NCT03454607

Foot Controlled Robotic Endoscope Enabled Robot FESS

Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot (FREE) in performing functional endoscopic sinus surgery to answer the two key questions: 1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery? 2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?

Detailed description

Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study

Conditions

• Sinusitis
• Polyp of Nasal Sinus

Interventions

Type	Name	Description
DEVICE	FREE robot	FREE robot to hold endoscope

Timeline

• Start date: 2018-01-04
• Primary completion: 2018-10-31
• Completion: 2018-11-30
• First posted: 2018-03-06
• Last updated: 2019-10-15

Locations

1 site across 1 country: Hong Kong