UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022169
Receipt No. 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 (Ver. 4)

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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
Last 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
Email nohmiya@fujita-hu.ac.jp

Public contact
1st 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
Email research@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025541