UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024252 |
|---|---|
| Receipt number | R000027924 |
| Scientific Title | Clinical research for safety and introduction of endoscopic sedation in private clinic |
| Date of disclosure of the study information | 2016/10/11 |
| Last modified on | 2019/04/03 12:16:21 |
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Basic information
Public title
Clinical research for safety and introduction of endoscopic sedation in private clinic
Acronym
Clinical research of endoscopic sedation in private clinic
Scientific Title
Clinical research for safety and introduction of endoscopic sedation in private clinic
Scientific Title:Acronym
Clinical research of endoscopic sedation in private clinic
Region
| Japan |
Condition
Condition
Patients scheduled to carry out esophagogastroduodenoscopy or colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of the sedation during gastrointestinal endoscopy in private clinic
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the frequency of adverse effects of sedation during gastrointestinal endoscopy
Key secondary outcomes
To evaluate the dose of sedative agents, the satisfaction of the patients and endoscopists for sedation, the management of adverse effects and the method of introduction of gastrointestinal endoscopy using sedation in private clinic
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The all patients who are carried out gastrointestinal endoscopy
Key exclusion criteria
1. The patients assigned to ASA classification 4-5
2. The patients with allergic to flunitrazepam
3. The female patients during pregnancy or lactating
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Imagawa |
Organization
Imagawa medical clinic
Division name
Gastroenterology
Zip code
769-1503
Address
285-3, Takeda, Kasada, Toyonaka, Mitoyo-city, Kagawa, Japan
TEL
0875-62-2052
imagawa-gi@nifty.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Imagawa |
Organization
Imagawa medical clinic
Division name
Gastroenterology
Zip code
769-1503
Address
285-3, Takeda, Kasada, Toyonaka, Mitoyo-city, Kagawa, Japan
TEL
0875-62-2052
Homepage URL
http://www.imagawanaika.jp/
imagawa-gi@nifty.com
Sponsor or person
Institute
Imagawa medical clinic
Institute
Department
Personal name
Funding Source
Organization
Imagawa medical clinic
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
Japan Gastroenterological Endoscopy Society
Address
Shin-ochanomizu Urban Trinity Bldg.4F, 3-2-1, Kandasurugadai, Chiyoda-ku, Tokyo, 101-0062, Japan
Tel
03-3525-4670
info@jges.or.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
| 2016 | Year | 10 | Month | 11 | 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
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design is clinical research for safety and introduction of endoscopic sedation in private clinic.
Methods: If the patient wants to use sedative agents, gastrointestinal endoscopy(EGD) is carried out with 0.2-0.4 mg of flunitrazepam (Rohypnol) as the basic dose. The target level of sedation is conscious sedation. The dose of flunitrazepam was adjusted according to the age and general condition of the patients.
Management information
Registered date
| 2016 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027924
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/04/02 | ⑤臨床研究計画書ver2.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
