UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058005 |
|---|---|
| Receipt number | R000066078 |
| Scientific Title | Development of a Continuous Lubricant Applying Device (Channel Smoother M: CS-M) for Working Channels Protection in Flexible Endoscopes and Study of Its Effectiveness in Reducing Forceps Insertion Stress |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/21 21:27:16 |
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Basic information
Public title
Development of a Continuous Lubricant Applying Device (Channel Smoother M: CS-M) for Working Channels Protection in Flexible Endoscopes and Study of Its Effectiveness in Reducing Forceps Insertion Stress
Acronym
Development of Channel Smoother M and verification study of lubrication effect
Scientific Title
Development of a Continuous Lubricant Applying Device (Channel Smoother M: CS-M) for Working Channels Protection in Flexible Endoscopes and Study of Its Effectiveness in Reducing Forceps Insertion Stress
Scientific Title:Acronym
Development of Channel Smoother M and verification study of lubrication effect
Region
| Japan |
Condition
Condition
Patients undergoing endoscopic submucosal dissection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate the usefulness of a novel device (Channel Smoother M: CS-M) that applies lubricant continuously and automatically, developed to protect working channels in flexible endoscopes. In a bench test, we will evaluate the effect of CS-M on the uniformity of lubricant application and dynamic friction force. In the clinical introduction phase, we aim to clarify whether CS-M contributes to reducing the burden of endoscopic procedures by evaluating the endoscopist's feeling of use and satisfaction during the procedure on a 5-point Likert scale.
Basic objectives2
Others
Basic objectives -Others
This study will evaluate the safety of a novel continuous lubricant application device (Channel Smoother M: CS-M). The presence or absence of any accidental or adverse events occurring during and immediately after endoscopic procedures while wearing the CS-M will be observed.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in dynamic friction force (bench test): The dynamic friction force (N) during instrument withdrawal with and without the new continuous lubricant application device (Channel Smoother M: CS-M) is compared to evaluate the lubrication effect.
Key secondary outcomes
1. evaluation of satisfaction with use (clinical evaluation): To evaluate the endoscopist's satisfaction with the use of the CS-M in clinical procedures using a 10-item, 5-point Likert scale at the end of the endoscopic procedure.
2. uniformity of lubricant application (bench test): To visually and qualitatively evaluate the uniformity of lubricant application to the surface of the instrument when the CS-M is applied.
3. number of device insertions (clinical evaluation): The number of times a device is inserted and removed per case will be recorded to quantitatively assess its use under the CS-M and to examine its impact on the usability of the CS-M.
4. treatment time (clinical evaluation): Treatment time (minutes) when the CS-M is used will be recorded, and its impact on practicality and work efficiency will be examined.
5. presence of contingencies (safety evaluation): To evaluate the occurrence of contingencies (device damage, infection, etc.) and adverse events associated with the use of the CS-M.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In this study, a continuous lubricant application device (Channel Smoother M: CS-M) is used to protect the working channels and reduce insertion stress during endoscopic procedures. The CS-M is attached to the endoscopic forceps opening before insertion of the instrument and has a mechanism to automatically and continuously apply lubricant to the device during the procedure. One of these devices is used per patient and the intervention is performed only during endoscopic submucosal dissection (ESD). The duration of the intervention is only one day on the day of the procedure, and the frequency of intervention is planned to be once per case, for a total of 10 cases; the CS-M will be used as a sterile disposable product, the lubricant is a medically compatible non-toxic glycerol base material, and all will be disposed of after the procedure. No medications or additional invasive interventions will be administered to patients.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing endoscopic submucosal dissection (ESD) using a flexible endoscope.
Key exclusion criteria
Patients for whom endoscopic treatment itself is considered high risk.
Patients who do not consent to the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime, Japan
TEL
0899605308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime, Japan
TEL
0899605308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Ehime Rosai Hospital, Japan Organization of Occupational Health and Safety
Address
13-27 Minami-Komatsubara-cho, Niihama-shi, Ehime, Japan
Tel
0897336191
ehimeh@m.johas.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛媛大学医学部附属病院（愛媛県）
愛媛労災病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066078
