SinusitisNCT03454607
Foot Controlled Robotic Endoscope Enabled Robot FESS
A study testing FREE robot in people with Sinusitis and Polyp of Nasal Sinus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Polyp of Nasal Sinus
- What is being tested?
- FREE robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jan 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing FESS surgery for benign pathology
Who cannot join
- 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
Show all 9Show fewer
- Untreated active infection
- Non-correctable coagulopathy
- Emergency Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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?
Read the 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
- Conditions
- Sinusitis, Polyp of Nasal Sinus
- Being tested
- FREE robot
- Keywords
- FREE, Robotic
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREE robotDevice
FREE robot to hold endoscope
| Study group | Role | What they receive |
|---|---|---|
| FREE robot | Experimental | Patients undergoing sinus surgery with the FREE robot Receives: Device: FREE robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion
The rate of conversions to normal holding of the endoscope
Measured: Intraoperative
Perioperative complications
Assessment of perioperative complications
Measured: Within 30 days postoperative
Secondary outcomes (4)
Surgical outcomes
Operative time
Measured: Intraoperative and postoperative 2 weeks and 30 days
Surgical outcomes
Estimated blood loss
Measured: Intraoperative and postoperative 2 weeks and 30 days
Surgical Outcomes
Length of stay
Measured: Intraoperative and postoperative 2 weeks and 30 days
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
Measured: Within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start4 Jan 2018
- Primary completion31 Oct 2018
- Study completion30 Nov 2018
Why it stopped: Difficulty in patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454607
- Sponsor's protocol ID
- CRE-2017.307-T
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03454607
- Acronym / sponsor ID
- CRE-2017.307-T
- Conditions
- Sinusitis, Polyp of Nasal Sinus
- Keywords
- FREE, Robotic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in patient recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FREE robot | Experimental | Device: FREE robotPatients undergoing sinus surgery with the FREE robot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing FESS surgery for benign pathology
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FREE robotFREE robot to hold endoscope | Device | FREE robot |
Primary outcome
Conversion
Time frame: Intraoperative
The rate of conversions to normal holding of the endoscope
Perioperative complications
Time frame: Within 30 days postoperative
Assessment of perioperative complications
4 secondary outcomes
Surgical outcomes
Time frame: Intraoperative and postoperative 2 weeks and 30 days
Surgical outcomes
Time frame: Intraoperative and postoperative 2 weeks and 30 days
Surgical Outcomes
Time frame: Intraoperative and postoperative 2 weeks and 30 days
Quality of life
Time frame: Within 30 days postoperative
Results and safety
The study was stopped early (reason given: Difficulty in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREE robot in people with Sinusitis and Polyp of Nasal Sinus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.