Foot Controlled Robotic Endoscope Enabled Robot FESS

Study Overview
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Brief Summary
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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: Is the FREE robot feasible to use in patients for endoscopic sinus surgery? Is the FREE robot safe to use in patients for endoscopic sinus surgery?

Detailed Description
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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

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

Conditions
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Sinusitis, Polyp of Nasal Sinus

Intervention / Treatment
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* Device: FREE robot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FREE robot<br>Patients undergoing sinus surgery with the FREE robot | Device: FREE robot<br>* FREE robot to hold endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion | The rate of conversions to normal holding of the endoscope | Intraoperative | 
| Perioperative complications | Assessment of perioperative complications | Within 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Operative time | Intraoperative and postoperative 2 weeks and 30 days | 
| Surgical outcomes | Estimated blood loss | Intraoperative and postoperative 2 weeks and 30 days | 
| Surgical Outcomes | Length of stay | Intraoperative and postoperative 2 weeks and 30 days | 
| Quality of life | 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 | Within 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FREE, Robotic