Foot Controlled Robotic Endoscope Enabled Robot FESS

The Chinese University of Hong Kong

Status: Terminated

Conditions: Polyp of Nasal Sinus; Sinusitis

Treatments: Device: FREE robot

Study type: Interventional

Funder types: Other

Identifiers

NCT03454607

CRE-2017.307-T

Details and patient eligibility

About

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?

Full 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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing FESS surgery for benign pathology

Exclusion criteria

• Pregnant/ lactating female patients
• Younger than 18 years of age
• Cognitive impairment or unable to provide informed consent
• Malignant sinus pathologies
• Previous endoscopic sinus surgery
• Contraindication to general anaesthesia
• Untreated active infection
• Non-correctable coagulopathy
• Emergency Surgery

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

FREE robot

Experimental group

Description:

Patients undergoing sinus surgery with the FREE robot

Treatment:

Device: FREE robot