Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060763) titled 'A study of the impact of a foot camera on endoscopic pedal operation' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Sano Hospital
Condition:
Condition - Healthy volunteers (Endoscopists)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the impact of a foot camera on pedal operation.
Basic objectives2 - Efficacy
Intervention:
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.
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 Size - 18
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 02 Day
Anticipated trial start date - 2026 Year 03 Month 27 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069498
Disclaimer: Curated by HT Syndication.