Biliary TractNCT04456218
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
A study testing NCKU-scope-01 (a custom-made biliary endoscope system) in people with Biliary Tract and Neoplasms, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Tract, Neoplasms, Stone - Biliary
- What is being tested?
- NCKU-scope-01 (a custom-made biliary endoscope system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 31 Dec 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complicated bile duct stone (stone size > 1.5 cm or number of stone > 3 )
- Patients with indeterminate biliary stricture or obstruction
Who cannot join
- Pregnant woman;
- Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.
- Conditions
- Biliary Tract, Neoplasms, Stone - Biliary
- Being tested
- NCKU-scope-01 (a custom-made biliary endoscope system)
- Medical subject headings
- Neoplasms, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCKU-scope-01 (a custom-made biliary endoscope system)Device
The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Biliary stone | Experimental | Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis. Receives: Device: NCKU-scope-01 (a custom-made biliary endoscope system) |
| Biliary stricture | Experimental | Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis. Receives: Device: NCKU-scope-01 (a custom-made biliary endoscope system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A complete common bile duct accessing rate
To test the device's feasibility
Measured: 1 day
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
Measured: 1 day
Secondary outcomes (3)
Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
To test the device's safety
Measured: 1 day
In biliary stone arm: The biggest residual stone size (in cm).
The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)
Measured: 1 day
In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary TractStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiao-Hsiung Chuang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456218
- Sponsor's protocol ID
- A-BR-108-097
- Status last verified
- Jul 2022
- First submitted
- 14 Jun 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
- ClinicalTrials.gov ID
- NCT04456218
- Acronym / sponsor ID
- A-BR-108-097
- Conditions
- Biliary Tract, Neoplasms, Stone - Biliary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Jul 2020 (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.
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary stone | Experimental | Device: NCKU-scope-01 (a custom-made biliary endoscope system)Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis. |
| Biliary stricture | Experimental | Device: NCKU-scope-01 (a custom-made biliary endoscope system)Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with complicated bile duct stone (stone size > 1.5 cm or number of stone > 3 )
- Patients with indeterminate biliary stricture or obstruction
Key exclusion criteria (2 listed)
- Pregnant woman;
- Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).
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 |
|---|---|---|
| NCKU-scope-01 (a custom-made biliary endoscope system)The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis | Device | Biliary stone, Biliary stricture |
Primary outcome
A complete common bile duct accessing rate
Time frame: 1 day
To test the device's feasibility
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
Time frame: 1 day
To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
3 secondary outcomes
Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
Time frame: 1 day
In biliary stone arm: The biggest residual stone size (in cm).
Time frame: 1 day
In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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 NCKU-scope-01 (a custom-made biliary endoscope system) in people with Biliary Tract and Neoplasms, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Aug 2022. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A complete common bile duct accessing rate (time frame: 1 day). 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 2 Aug 2022.