UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058845 |
|---|---|
| Receipt number | R000067288 |
| Scientific Title | An Observational Study on Lower Limb Load in Endoscopists |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/19 23:25:52 |
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Basic information
Public title
An Observational Study on Lower Limb Load in Endoscopists
Acronym
A Study on Lower Limb Load in Endoscopists
Scientific Title
An Observational Study on Lower Limb Load in Endoscopists
Scientific Title:Acronym
A Study on Lower Limb Load in Endoscopists
Region
| Japan |
Condition
Condition
endoscopist
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of weight bearing on the lower limbs during endoscopic procedures, including ESD (endoscopic submucosal dissection).
Basic objectives2
Others
Basic objectives -Others
Measurement of weight bearing on the lower limbs during endoscopic procedures, including ESD (endoscopic submucosal dissection).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lateral displacement of lower limb weight bearing during endoscopy and its duration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) Physicians employed at Yokohama City University Hospital who voluntarily agree to participate in the study.
2) Physicians who plan to perform upper or lower gastrointestinal endoscopy or ESD during the study period.
3) Physicians who performed a total of 100 or more upper and lower gastrointestinal endoscopies and 30 or more ESD procedures at Yokohama City University Hospital between January and December 2024
4) Physicians who consented to load measurement during diagnostic endoscopy and obtained written informed consent
Key exclusion criteria
1) Individuals with obvious orthopedic disorders (lower limbs, lumbar spine, hip joints, etc.) that interfere with walking or standing.
2) Individuals who are pregnant or may be pregnant.
3) Individuals for whom it is difficult to attach the measuring device, or for whom attachment of the device is judged to interfere with endoscopic operation.
4) Other individuals whom the principal investigator or co-investigator judges to be unsuitable for participation in this study.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Misawa |
Organization
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.
Division name
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
nobomisa@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Misawa |
Organization
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama
Division name
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
09061961466
Homepage URL
nobomisa@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
none
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
Yokohama City University Affiliated Research Ethics Committee for Life Sciences and Medical Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0457872800
nobomisa@hotmail.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 20 | 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
| 2025 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067288
