UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052830 |
|---|---|
| Receipt number | R000060193 |
| Scientific Title | A retrospective study of the effectiveness of EC-760XP/L in patients with difficult colonoscopy insertion |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/17 19:35:55 |
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Basic information
Public title
A retrospective study of the effectiveness of EC-760XP/L in patients with difficult colonoscopy insertion
Acronym
A retrospective study of the effectiveness of EC-760XP/L in patients with difficult colonoscopy insertion
Scientific Title
A retrospective study of the effectiveness of EC-760XP/L in patients with difficult colonoscopy insertion
Scientific Title:Acronym
Efficacy of EC-760XP/L in patients with difficult colonoscopy insertion
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the usefulness and safety of EC-760XP/L
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cecal intubation rate
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
| 18 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients whose previous examination was difficult to insert or caused severe pain
Key exclusion criteria
Patients who have not been examined in our hospital,patients whose previous examination was preoperative, and patients whose examiner has less than 500 cases of experience.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichijima |
| Middle name | |
| Last name | Ryoji |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
173-8610
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.
TEL
03-3972-8111
ryoji0331@yahoo.co.jp.
Public contact
Name of contact person
| 1st name | Terada |
| Middle name | |
| Last name | Rie |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
173-8610
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.
TEL
03-3972-8111
Homepage URL
terada.rie@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
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
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Address
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Tel
03-3972-8111
terada.rie@nihon-u.ac.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
日本大学医学部付属板橋病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 17 | 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
92
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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center, retrospective study
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060193
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
