UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062632 |
|---|---|
| Receipt number | R000071692 |
| Scientific Title | Study of Nasogastric Tube Placement Using a Light-Guided Catheter System |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/20 11:57:12 |
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Basic information
Public title
Study of nasogastric tube placement using a light-guided tube positioning system
Acronym
Light-Guided NG Tube Study
Scientific Title
Study of Nasogastric Tube Placement Using a Light-Guided Catheter System
Scientific Title:Acronym
GtPS Study
Region
| Japan |
Condition
Condition
Hospitalized patients requiring nasogastric tube placement, irrespective of underlying disease
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the use of a light-guided catheter system during nasogastric tube placement improves procedural operability and may allow omission of radiographic confirmation after tube placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between the nasogastric tube tip position confirmed by abdominal radiography after tube placement and the position identified using the light-guided catheter system.
Key secondary outcomes
Operator-reported procedural operability, safety, and visibility assessed using a five-point questionnaire and free-text comments after nasogastric tube placement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In patients clinically requiring nasogastric tube placement, the MET Light-Guided Catheter System is used concomitantly during nasogastric tube insertion and placement. The light-guided catheter is inserted into the nasogastric tube, and the position of the light source is assessed transcutaneously during and after tube placement. After tube placement, abdominal radiography is performed as part of standard clinical care, and the tube-tip position confirmed by radiography is compared with the position identified using the light-guided catheter system. The intervention is performed at each nasogastric tube placement procedure.
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
Patients aged 18 years or older who are clinically judged to require nasogastric tube placement and for whom written informed consent is obtained from the patient or an appropriate legally authorized representative.
Key exclusion criteria
Patients for whom informed consent for participation in the study cannot be obtained.
Patients with a cardiac pacemaker.
Patients with an implantable cardioverter-defibrillator (ICD).
Target sample size
880
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mato |
Organization
Jichi Medical University
Division name
Department of Emergency Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL
0285-58-7395
mato_stm@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Chikara |
| Middle name | |
| Last name | Yonekawa |
Organization
Jichi Medical University
Division name
Department of Emergency Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL
0285-58-7395
Homepage URL
yone-c@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Nihon Ash Co., Ltd. (in-kind provision of light-guided catheters used in the study)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
Tel
0285-58-8933
rinri@jichi.ac.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
自治医科大学附属病院（栃木県）、東京大学医学部附属病院（東京都）、日本医科大学付属病院（東京都）、獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071692
