UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046204 |
|---|---|
| Receipt number | R000052730 |
| Scientific Title | Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2021/11/26 21:35:09 |
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Basic information
Public title
Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Acronym
Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Scientific Title
Comparison of cold snare polypectomy for sessile serrated lesions larger than 10 mm between expert and non-expert endoscopists
Scientific Title:Acronym
Comparison of CSP for SSLs larger than 10 mm between expert and non-expert endoscopists
Region
| Japan |
Condition
Condition
Sessile serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the safety and efficacy of CSP for the treatment of SSLs larger than 10 mm performed by both expert and non-expert
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete resection rate, en bloc resection rate, adverse event rate, and procedure time
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Cold snare polypectomy
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 with 10mm or more SSL
Key exclusion criteria
Lesions with the following endoscopic findings associated with cytological dysplasia or cancer
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kimoto |
| Middle name | |
| Last name | Yoshiaki |
Organization
NTT Medical Center Tokyo
Division name
Division of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
kimoto.yoshiaki@gmail.com
Public contact
Name of contact person
| 1st name | Kimoto |
| Middle name | |
| Last name | Yoshiaki |
Organization
NTT Medical Center Tokyo
Division name
Division of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6111
Homepage URL
kimoto.yoshiaki@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
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
NTT Medical Center Tokyo
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
Tel
03-3448-6111
kimoto.yoshiaki@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
No. 18-81
Org. issuing International ID_1
NTT Medical Center Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
