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Foot Controlled Robotic Endoscope Enabled Robot FESS

Primary Purpose

Sinusitis, Polyp of Nasal Sinus

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
FREE robot
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sinusitis focused on measuring FREE, Robotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FREE robot

Arm Description

Patients undergoing sinus surgery with the FREE robot

Outcomes

Primary Outcome Measures

Conversion
The rate of conversions to normal holding of the endoscope
Perioperative complications
Assessment of perioperative complications

Secondary Outcome Measures

Surgical outcomes
Operative time
Surgical outcomes
Estimated blood loss
Surgical Outcomes
Length of stay
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

Full Information

First Posted
December 27, 2017
Last Updated
October 12, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03454607
Brief Title
Foot Controlled Robotic Endoscope Enabled Robot FESS
Official Title
Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in patient recruitment
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Polyp of Nasal Sinus
Keywords
FREE, Robotic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FREE robot
Arm Type
Experimental
Arm Description
Patients undergoing sinus surgery with the FREE robot
Intervention Type
Device
Intervention Name(s)
FREE robot
Intervention Description
FREE robot to hold endoscope
Primary Outcome Measure Information:
Title
Conversion
Description
The rate of conversions to normal holding of the endoscope
Time Frame
Intraoperative
Title
Perioperative complications
Description
Assessment of perioperative complications
Time Frame
Within 30 days postoperative
Secondary Outcome Measure Information:
Title
Surgical outcomes
Description
Operative time
Time Frame
Intraoperative and postoperative 2 weeks and 30 days
Title
Surgical outcomes
Description
Estimated blood loss
Time Frame
Intraoperative and postoperative 2 weeks and 30 days
Title
Surgical Outcomes
Description
Length of stay
Time Frame
Intraoperative and postoperative 2 weeks and 30 days
Title
Quality of life
Description
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
Time Frame
Within 30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Foot Controlled Robotic Endoscope Enabled Robot FESS

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