Foot Controlled Robotic Endoscope Enabled Robot FESS | NCT03454607

Studies
Foot Controlled Robotic Endoscope Enabled Robot FESS

NCT03454607

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Oct 15, 2019Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Sinusitis
Polyp of Nasal Sinus

Interventions

FREE robot

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in patient recruitment

Expanded Access Info

Start Date

Jan 4, 2018Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Dec 27, 2017

First Submission Date that Met QC Criteria

Mar 3, 2018

First Posted Date

Mar 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2019

Last Update Posted Date

Oct 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FREE robot	Experimental	Patients undergoing sinus surgery with the FREE robot	Device: FREE robot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FREE robot	Device	FREE robot to hold endoscope	FREE robot

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Surgical outcomes	Operative time	Intraoperative and postoperative 2 weeks and 30 days
Surgical outcomes	Estimated blood loss	Intraoperative and postoperative 2 weeks and 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong		Shatin			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012852	Sinusitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided