UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047366 |
|---|---|
| Receipt number | R000053891 |
| Scientific Title | A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope |
| Date of disclosure of the study information | 2022/04/02 |
| Last modified on | 2022/04/02 08:58:46 |
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Basic information
Public title
A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Acronym
A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Scientific Title
A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Scientific Title:Acronym
A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Region
| Japan |
Condition
Condition
Patients scheduled for upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and evaluate the effect of a transoral endoscopy with an ultrathin endoscope on distress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction compared to conventional diameter transoral upper gastrointestinal endoscopy
Key secondary outcomes
Physician satisfaction with examination, examination time, biopsy site, time taken to biopsy, biopsy success rate, failure to diagnose by pathology, tumor detection rate, and primary endpoint results by skilled and unskilled physicians
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
| Device,equipment |
Interventions/Control_1
ultrathin endoscopy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are 20 years old or older at the time consent is obtained.
(2) Patients have been fully informed about participation in the research, fully understand the circumstances, and consent in writing of his/her own free will.
Key exclusion criteria
(1) Patients who have refused to participate in this study
(2) Patients who are considered by the investigator or sub-investigator as not suitable for participation in this study
(3) Patients with serious cardiopulmonary diseases or coagulation disorders
(4) Patients allergic to Xylocaine
(5) Patients who cannot fill out the questionnaire by themselves
(6) Patients who have undergone upper gastrointestinal tract surgery
(7) Patients with known upper gastrointestinal lesions for which endoscopic or surgical treatment is planned.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | AYA |
| Middle name | |
| Last name | IWAO |
Organization
Nihon University Hospital
Division name
Gastroenterology
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL
03-3293-1711
iwao.aya@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | AYA |
| Middle name | |
| Last name | IWAO |
Organization
Nihon University Hospital
Division name
Gastroenterology
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL
03-3293-1711
Homepage URL
iwao.aya@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
No
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 Hospital Clinical Research Review Committee
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
Tel
03-3293-1711
iwao.aya@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 02 | 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
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053891
| 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 |
