Foot Controlled Robotic Endoscope Enabled Robot FESS

NCT ID: NCT03454607

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2018-11-30

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:

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

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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

Conditions

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Sinusitis Polyp of Nasal Sinus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FREE robot

Patients undergoing sinus surgery with the FREE robot

Group Type EXPERIMENTAL

FREE robot

Intervention Type DEVICE

FREE robot to hold endoscope

Interventions

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FREE robot

FREE robot to hold endoscope

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Jason Chan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CRE-2017.307-T

Identifier Type: -

Identifier Source: org_study_id

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