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

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 - Development of Channel Smoother M and verification study of lubrication effect

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058005

Enrollment

Registered

2025-06-01

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing endoscopic submucosal dissection

Interventions

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 attach

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 addi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing endoscopic submucosal dissection (ESD) using a flexible endoscope.

Exclusion criteria

Exclusion criteria: Patients for whom endoscopic treatment itself is considered high risk. Patients who do not consent to the study.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactKazuki Niida

Ehime University Graduate School of Medicine Department of Advanced and Innovative Endoscopy

3naika@m.ehime-u.ac.jp0899605308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026