UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053841 |
|---|---|
| Receipt number | R000061451 |
| Scientific Title | Durability and efficacy of a novel transparent silicon attachment "Static Electricity Fastening Tape-hood." |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2025/10/04 06:05:18 |
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Basic information
Public title
Durability and efficacy of a novel transparent silicon attachment "Static Electricity Fastening Tape-hood."
Acronym
Durability and efficacy of a novel transparent silicon attachment "Static Electricity Fastening Tape-hood."
Scientific Title
Durability and efficacy of a novel transparent silicon attachment "Static Electricity Fastening Tape-hood."
Scientific Title:Acronym
Durability and efficacy of a novel transparent silicon attachment "Static Electricity Fastening Tape-hood."
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate durability and efficacy of a novel transparent silicon attachment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The completion rate of colonoscopy without SET hood detachment.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
colonoscopy using a novel transparent silicon attachment
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing screening or surveillance colonoscopies
Key exclusion criteria
1) Colonic polyps have been noted and are being followed up.
2) Solid or muddy stools occupy more than about 50% of the colon due to poor preparation, and the colonoscope cannot be inserted safely and smoothly.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Takayanagi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
Homepage URL
stakayanagi125@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
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
NTT medical center Tokyo Ethics Committee
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
Tel
0334486111
stakayanagi125@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
| 2024 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061451
