UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060763 |
|---|---|
| Receipt number | R000069498 |
| Scientific Title | A prospective study of the impact of a foot camera on pedal operation |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/26 21:05:52 |
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Basic information
Public title
A study of the impact of a foot camera on endoscopic pedal operation
Acronym
The Foot-Camera Study
Scientific Title
A prospective study of the impact of a foot camera on pedal operation
Scientific Title:Acronym
The Foot-Camera Study
Region
| Japan |
Condition
Condition
Healthy volunteers (Endoscopists)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of a foot camera on pedal operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean reaction time of foot pedal operation in each condition
Key secondary outcomes
1.Median reaction time of foot pedal operation
2.Presence and number of incorrect inputs (mistyping)
3.Accuracy rate of pedal operation
4.Number of downward gaze shifts for foot pedal confirmation (calculated from lateral video recordings)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Foot camera group: Subjects perform the pedal operation task with the foot camera image displayed on the monitor. While subjects primarily refer to the monitor image for operation, direct visual confirmation of the feet is not restricted and is left to the discretion of each subject.
Interventions/Control_2
No-camera group: Subjects perform the task in a standard environment without the foot camera image. No specific rules are set for direct visual confirmation of the feet, allowing for natural behavior consistent with daily clinical practice.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Physicians engaged in gastrointestinal endoscopic treatment
2.Individuals who provided written informed consent to participate in this study
Key exclusion criteria
1.Physicians with no clinical experience in endoscopic treatment using foot pedals
2.Individuals with pain or motor dysfunction in the foot or lower limbs that interferes with foot pedal operation
3.Individuals for whom accurate evaluation is difficult due to data loss or equipment trouble
4.Individuals who withdrew their consent to participate in the study
5.Others deemed unsuitable or difficult to participate in the study by the principal investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Riku |
| Middle name | |
| Last name | Nakajima |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
655-0031
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
078-785-1000
nakajimar2020@gmail.com
Public contact
Name of contact person
| 1st name | Riku |
| Middle name | |
| Last name | Nakajima |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
078-785-1000
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
078-785-1000
Homepage URL
nakajimar2020@gmail.com
Sponsor or person
Institute
Sano Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Medical Corporation Kunpukai
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
Tel
078-785-1000
yonedarieko@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069498
