UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053043 |
|---|---|
| Receipt number | R000060517 |
| Scientific Title | Prospective sampling, multicenter study to determine the actual conditions of endoscopy and treatment and sedation to reduce patient distress. |
| Date of disclosure of the study information | 2023/12/09 |
| Last modified on | 2023/12/09 11:59:20 |
* 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
Prospective sampling, multicenter study to determine the actual conditions of endoscopy and treatment and sedation to reduce patient distress.
Acronym
Prospective sampling, multicenter study to determine the actual conditions of endoscopy and treatment and sedation to reduce patient distress.
Scientific Title
Prospective sampling, multicenter study to determine the actual conditions of endoscopy and treatment and sedation to reduce patient distress.
Scientific Title:Acronym
Prospective sampling, multicenter study to determine the actual conditions of endoscopy and treatment and sedation to reduce patient distress.
Region
| Japan |
Condition
Condition
Patients undergoing X-ray or endoscopic examinations or treatments
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopy and treatment are invasive and, although individual differences exist, involve patient pain and stress. In recent years, advances in sedation have made it possible to perform endoscopic examinations and treatments while reducing patient pain. However, it is still unclear what type of sedation leads to improved patient satisfaction. The significance of this study is to understand the actual status of sedation techniques that lead to high patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction with examination and treatment
Key secondary outcomes
Satisfaction of medical staff with examination and treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: 18 years old or older
Gender: any gender
Eligibility: Patients undergoing X-ray or endoscopic examination and treatment
Key exclusion criteria
Patients who cannot give their consent to participate in this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International University of Health and Welfare Narita Hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852 Hataketa, Narita City, Chiba Prefecture
TEL
0476355600
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
International university health and welfare Narita hospital
Institute
Department
Personal name
Funding Source
Organization
International university health and welfare Narita hospital
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
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
takaomi0027@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
| 2023 | Year | 12 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060517
