NCT03454607

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. 1.Is the FREE robot feasible to use in patients for endoscopic sinus surgery?
  2. 2.Is the FREE robot safe to use in patients for endoscopic sinus surgery?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

December 27, 2017

Last Update Submit

October 12, 2019

Conditions

SinusitisPolyp of Nasal Sinus

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

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

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

Primary Completion

October 31, 2018

Study Completion

November 30, 2018

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)