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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031288
Receipt No. R000035719
Scientific Title The applicability of endoscopic hand-suturing method by using through-the-scope needle holder.
Date of disclosure of the study information 2018/02/13
Last modified on 2020/08/18

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Basic information
Public title The applicability of endoscopic hand-suturing method by using through-the-scope needle holder.
Acronym The applicability of endoscopic hand-suturing method
Scientific Title The applicability of endoscopic hand-suturing method by using through-the-scope needle holder.
Scientific Title:Acronym The applicability of endoscopic hand-suturing method
Region
Japan

Condition
Condition Esophagus Achalasia etc
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and effectiveness of endoscopic hand-suturing method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of endoscopic hand suturing method at the next day, 2 months and 1 year after the operation.
Key secondary outcomes Adverse events rate.

Patients are evaluated by obtaining blood samples and X-rays after the operation(operation day and next day).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Procedure by EHS
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have received complete information about the study and are willing to provide written informed consent.
Key exclusion criteria Inability or unwillingness of patients to give written informed consent
Judged unsuitable for this study by the physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Haruhiro
Middle name
Last name Inoue
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code 1358577
Address 5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL 03-6204-6000
Email haru.inoue@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Toshimori
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code 1358577
Address 5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL 03-6204-6000
Homepage URL
Email akikotoshimori@med.showa-u.ac.jp

Sponsor
Institute Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization Showa University Koto Toyosu Hospital
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 Showa University Koto Toyosu Hospital
Address 5-1-38, Toyosu, Koto-ku, Tokyo, Japan
Tel 03-6204-6000
Email th_irb@ofc.showa-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 13 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
2017 Year 09 Month 29 Day
Date of IRB
2017 Year 09 Month 28 Day
Anticipated trial start date
2017 Year 11 Month 27 Day
Last follow-up date
2022 Year 12 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
2018 Year 02 Month 13 Day
Last modified on
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035719

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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