UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034666 |
|---|---|
| Receipt number | R000038415 |
| Scientific Title | Endoscopic diverculectomy for Zenker diverticulum -multicenter study- |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2022/04/29 03:04:11 |
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Basic information
Public title
Endoscopic diverculectomy for Zenker diverticulum -multicenter study-
Acronym
Endoscopic diverculectomy
Scientific Title
Endoscopic diverculectomy for Zenker diverticulum -multicenter study-
Scientific Title:Acronym
Endoscopic diverculectomy
Region
| Japan |
Condition
Condition
Zenker diverticulum
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the endoscopic diverticulectomy for Zenker diverticulum.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and effectiveness of Zenker diverticulectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
diverticulectomy
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Symptomatic patients with Zenker diverticulum
Key exclusion criteria
1) Patients having another severe disorders
2) Patients who can not open the mouth widely
3) Patients who are judged by the investigators to be inappropriate participants in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Terai |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
9518510
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-227-2207
terais@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
9518510
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-227-2207
Homepage URL
pyloki-sato@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ethics Committee of Niigata University
Address
757, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
Tel
025-227-2625
ethics@adm.niigata-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
新潟大学病院、長岡赤十字病院、新潟市民病院、長岡中央綜合病院 （新潟県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
6
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
| 2018 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038415
