NCT03454607

Terminated

Foot Controlled Robotic Endoscope Enabled Robot FESS

Chinese University of Hong Kong Source

Chinese University of Hong Kong

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CRE-2017.307-T

Study Type

interventional

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

January 4, 2018

Actual (reported)

Primary Completion

October 31, 2018

Actual (reported)

Study Completion

November 30, 2018

Actual (reported)

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:

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?

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 1 participants
Study completion date: November 30, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 27, 2017
Actual (reported)
Study Start
January 4, 2018
Actual (reported)
First Posted
March 6, 2018
Actual (reported)
Primary Completion
October 31, 2018
Actual (reported)
Study Completion
November 30, 2018
Actual (reported)

Last Updated: October 15, 2019
Status Verified: October 2019
Last Update Submitted: October 12, 2019

Conditions

Polyp of Nasal Sinus Sinusitis

Keywords

FREERobotic

Outcome Measures

Primary Outcomes (2)

Conversion
The rate of conversions to normal holding of the endoscope
Intraoperative
Perioperative complications
Assessment of perioperative complications
Within 30 days postoperative

Secondary Outcomes (4)

Surgical outcomes
Intraoperative and postoperative 2 weeks and 30 days
Surgical outcomes
Intraoperative and postoperative 2 weeks and 30 days
Surgical Outcomes
Intraoperative and postoperative 2 weeks and 30 days
Quality of life
Within 30 days postoperative

Study Arms (1)

FREE robot

EXPERIMENTAL

Patients undergoing sinus surgery with the FREE robot

Device: FREE robot

Interventions

FREE robotDevice

FREE robot to hold endoscope

FREE robot

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Undergoing FESS surgery for benign pathology

You may not qualify if:

Sponsors & Collaborators

Chinese University of Hong Kong
Otherlead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

December 27, 2017

First Posted

March 6, 2018

Study Start

January 4, 2018

Actual (reported)

NCT02506426

Endoscopic Sinus Surgery for Refractory Chronic Sinusitis

Not ApplicableUnknown

NCT03584178

The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis

Not ApplicableUnknown

NCT02924103

Contamination Free Bacterial Swap

Not ApplicableCompleted

NCT02077322

Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

Not ApplicableCompleted

NCT02278484

Sinus Balloon Dilation in Pediatric Patients

Not ApplicableCompleted

NCT03036735

Rates of Middle Meatus Synechiae Formation Post ESS

Not ApplicableTerminated

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

Contact the study team to confirm eligibility.

Primary Completion

October 31, 2018

Actual (reported)

Study Completion

November 30, 2018

Actual (reported)

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT03454607
Data provider: ClinicalTrials.gov
Source updated: 2019-10-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:38 UTC

Locations

HK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

FREE robot

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations