UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031288 |
|---|---|
| Receipt number | 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 12:19:14 |
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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
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
akikotoshimori@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035719
