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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006545
Receipt No. R000007734
Scientific Title A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Date of disclosure of the study information 2011/10/30
Last modified on 2011/10/30

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Basic information
Public title A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Acronym A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Scientific Title A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Scientific Title:Acronym A prospective comparative study to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Region
Japan

Condition
Condition gastric tumors
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Endoscopic submucosal dissection (ESD) for early gastric neoplasms enables to resect in en block. However, major complication about ESD is post bleeding. The aim of this study is to investigate whether an infrared imaging (IRI) system has potential to reduce the post ESD bleeding.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes to determine whether an infrared imaging system can prevent bleeding after endoscopic submucosal dissection.
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria A total of 24 patients (25 lesions) were consecutively enrolled in this study between March 2010 and December 2010 at our hospital.
Key exclusion criteria Exclusion criteria were as follows: 1) patients with a bleeding tendency (liver cirrhosis, dialysis); or 2) age >80 years or <20 years.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yukinaga yoshida
Organization Jikei University Aoto hospital
Division name Department of Endoscopy
Zip code
Address 6-41-2,Aoto Katsushika-ku, Tokyo,Japan
TEL +81-3-3603-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name yukinaga yoshida
Organization Jikei University Aoto Hospital
Division name Department of Endoscopy
Zip code
Address 6-41-2,Aoto Katsushika-ku, Tokyo,Japan
TEL
Homepage URL
Email

Sponsor
Institute Jikei University school of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 東京慈恵会医科大学附属青戸病院

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 30 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 Completed
Date of protocol fixation
2010 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information Only gray points on IRI corresponded with a risk of bleeding. Thus, limiting coagulation to these points, with special attention to the peripheral area of the ulcer, may reduce unnecessary coagulation and reduce procedural time while still minimizing the risk of delayed bleeding.

Management information
Registered date
2011 Year 10 Month 14 Day
Last modified on
2011 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007734

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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