UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056629 |
|---|---|
| Receipt number | R000064703 |
| Scientific Title | Prospective Observational Study on the Trasnasal Bronchoscopy tolerability in Non-Tuberculous Mycobacteriosis |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/01/05 11:56:03 |
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Basic information
Public title
A Study to Evaluate the Patient Burden of Transnasal Endoscopy for Diagnosis of Non-Tuberculous Mycobacterial Disease
Acronym
TRANSIT-NTM study
Scientific Title
Prospective Observational Study on the Trasnasal Bronchoscopy tolerability in Non-Tuberculous Mycobacteriosis
Scientific Title:Acronym
TRANSIT-NTM study
Region
| Japan |
Condition
Condition
Non-Tuberculous mycobacteriosis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the degree of patient distress, such as dyspnoea symptoms and pain, during nasal bronchoscopy for patients with NTM.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distress scores reported by subjects after bronchoscopy. The distress score is based on a questionnaire form proposed by the Japan Society for Respiratory Endoscopy, with a five-point scale for each of the following five items: dyspnoea during the examination, pain during the examination, mood after the examination, whether the examination time felt long, and whether the examination should be repeated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Questionnaire survey of subjects after nasal bronchoscopy.
Interventions/Control_2
Questionnaire survey of subjects after oral bronchoscopy.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years and over who visited the hospital between 1 October 2024 and 31 March 2026 and underwent bronchoscopy for the diagnosis of non-tuberculous mycobacteriosis.
Key exclusion criteria
Patients with psychiatric disorders or dementia who have difficulty completing the questionnaire.
Patients with factors that may influence the level of distress, such as those taking analgesics such as NSAIDs or opioids, sleep aids, antipsychotics, allergic to local anaesthetics, chronic respiratory failure, pregnant or lactating women.
Patients with a history of at least one previous bronchoscopy or upper gastrointestinal endoscopy or a history of head and neck surgery or surgery for pulmonary disease, as patients with factors influencing the subjective factors in the questionnaire.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Usui |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
+81-3-3762-4151
yuusuke.usui@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Usui |
Organization
Toho University Omori Medical Center
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
+81-3-3762-4151
Homepage URL
yuusuke.usui@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
None
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
Toho University Omori Medical Center
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
Tel
03-5763-6534
omori.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M24101
Org. issuing International ID_1
Ethics Committee of Toho University Omori Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 01 | Month | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064703
