Foot Controlled Robotic Endoscope Enabled Robot FESS

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03454607
• Other study ID #: CRE-2017.307-T
• Status: Terminated
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 30, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polyp of Nasal Sinus
• Sinusitis

Intervention

Device:
• FREE robot
FREE robot to hold endoscope

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion	The rate of conversions to normal holding of the endoscope	Intraoperative
Primary	Perioperative complications	Assessment of perioperative complications	Within 30 days postoperative
Secondary	Surgical outcomes	Operative time	Intraoperative and postoperative 2 weeks and 30 days
Secondary	Surgical outcomes	Estimated blood loss	Intraoperative and postoperative 2 weeks and 30 days
Secondary	Surgical Outcomes	Length of stay	Intraoperative and postoperative 2 weeks and 30 days
Secondary	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