Foot Controlled Robotic Endoscope Enabled Robot FESS

Not Applicable

Terminated

• Conditions: Polyp of Nasal Sinus; Sinusitis
• Interventions: Device: FREE robot

• Registration Number: NCT03454607
• Lead Sponsor: Chinese University of Hong Kong

Brief 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

Study Timeline

• Study First Submitted: 2017-12-27
• Study Start: 2018-01-04
• Study First Submitted QC: 2018-03-03
• Study First Posted: 2018-03-06
• Primary Completion: 2018-10-31
• Study Completion: 2018-11-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-12
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Undergoing FESS surgery for benign pathology

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FREE robot	FREE robot	Patients undergoing sinus surgery with the FREE robot

Primary Outcome Measures

Name	Time	Method
Conversion	Intraoperative	The rate of conversions to normal holding of the endoscope
Perioperative complications	Within 30 days postoperative	Assessment of perioperative complications

Secondary Outcome Measures

Name	Time	Method
Surgical outcomes	Intraoperative and postoperative 2 weeks and 30 days	Estimated blood loss
Surgical Outcomes	Intraoperative and postoperative 2 weeks and 30 days	Length of stay
Quality of life	Within 30 days postoperative	The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Higher scores represent a worse outcome

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong