Foot Controlled Robotic Endoscope Enabled Robot FESS

October 12, 2019 updated by: Jason Chan, Chinese University of Hong Kong

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

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?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FREE robot
Patients undergoing sinus surgery with the FREE robot
Device: FREE robot
FREE robot to hold endoscope

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

March 3, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 12, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2017.307-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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