UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024252
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email imagawa-gi@nifty.com

Sponsor
Institute Imagawa medical clinic
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.