UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022169 |
|---|---|
| Receipt number | R000025541 |
| Scientific Title | Comparative study between Full Spectrum Endoscopy (FUSE) gastroscopy and conventional esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2019/05/05 11:33:46 |
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Basic information
Public title
Comparative study between Full Spectrum Endoscopy (FUSE) gastroscopy and conventional esophagogastroduodenoscopy
Acronym
FUSE gastroscopy vs esophagogastroduodenoscopy
Scientific Title
Comparative study between Full Spectrum Endoscopy (FUSE) gastroscopy and conventional esophagogastroduodenoscopy
Scientific Title:Acronym
FUSE gastroscopy vs esophagogastroduodenoscopy
Region
| Japan |
Condition
Condition
Established or suspected upper gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Current esophagogastroduodenoscopy(EGD) or duodenoscopy uses only the front view or the side view, the angle of which is 170 or 100 degrees, respectively. EndoChoice has launched Full Spectrum Endoscopy(FUSE). FUSE gastroscopy has both one side view and the front view (in total 210 degrees). In this study, we compare the detection rates of upper gastrointestinal diseases between FUSE gastroscopy and conventional EGD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Detection rates of upper gastrointestinal disease
Key secondary outcomes
Examination time
Changes in vital signs
Incidence of adverse events
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with established or suspected upper gastrointestinal diseases
Key exclusion criteria
1. Patients with adverse events such as perforation.
2. Patients with upper gastrointestinal stenosis
3. Patients inappropriate for this study by other reasons judged by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Gastroenterology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Ikue |
| Middle name | |
| Last name | Tanigawa |
Organization
Fujita Health University School of Medicine
Division name
IRB
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562932860
Homepage URL
research@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
IRB
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562932860
research@fujita-hu.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
藤田保健衛生大学第一病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
103
Results
The successful visualization rates of MDP and the anal side of the pyloric ring in the FUSE group were significantly higher than those in the conventional EGD group; 83.4% vs. 35.1% for MDP (P<0.001) and 86.4% vs. 7.1% for the anal side of the pyloric ring (P<0.001), respectively.
Results date posted
| 2019 | Year | 05 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Detectability of diseases or normal findings in upper gastrointestinal tract
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025541
