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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032526
Receipt No. R000037095
Scientific Title Clinical study for the safety and efficacy of the hydrogen breath test
Date of disclosure of the study information 2018/05/14
Last modified on 2018/05/09

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Basic information
Public title Clinical study for the safety and efficacy of the hydrogen breath test
Acronym The safety and efficacy of the hydrogen breath test
Scientific Title Clinical study for the safety and efficacy of the hydrogen breath test
Scientific Title:Acronym The safety and efficacy of the hydrogen breath test
Region
Japan

Condition
Condition Digestive disease, healthy adult
Classification by specialty
Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirmation of the safety and efficacy of the hydrogen breath test
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The concentration measurement of the breath hydrogen using Gastrolyser
Key secondary outcomes Changes in the breath hydrogen concentration due to circadian rhythm, lactose consumption, hydrogen inhalation, platinum antitumor agent administration and surgical intervention.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who are informed to the fullest extent about the purposes and contents of the study, have the ability to give consent, volunteer for participation after having fully understood, and agree to participate in the study writing.
Key exclusion criteria Patients who reject to participate in this study
Patients whom the investigator considers inappropriate for entry into the trial.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruo Kiyama
Organization TMG Asaka Medical Center
Division name Department of Surgery
Zip code
Address 1340-1 Mizonuma, Asaka, Saitama
TEL 048-466-2055
Email kiyama@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruo Kiyama
Organization TMG Asaka Medical Center
Division name Department of Surgery
Zip code
Address 1340-1 Mizonuma, Asaka, Saitama
TEL 048-466-2055
Homepage URL
Email kiyama@nms.ac.jp

Sponsor
Institute Department of Surgery
TMG Asaka Medical Center
Institute
Department

Funding Source
Organization Department of Surgery
TMG Asaka Medical Center
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
Address
Tel
Email

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 TMGあさか医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 14 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
2018 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2018 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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