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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037348
Receipt No. R000042574
Scientific Title Flexible endoscopic treatment for Zenker's diverticulum: Observational study of an existing treatment.
Date of disclosure of the study information 2019/07/20
Last modified on 2019/09/26

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Basic information
Public title Flexible endoscopic treatment for Zenker's diverticulum: Observational study of an existing treatment.
Acronym FESD for ZD
Scientific Title Flexible endoscopic treatment for Zenker's diverticulum: Observational study of an existing treatment.
Scientific Title:Acronym FESD for ZD
Region
Japan

Condition
Condition Zenker's diverticulum
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess prospectively short and long-term outcome of existing flexible endoscopic treatment of ZD including success, complication and recurrence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical success rate
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 flexible endoscopic septum division (FESD)
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 - Diagnosed as ZD with symptoms
- ASA score of > 3
- age of more than 20
Key exclusion criteria - previous upper gastrointestinal surgery
- previous treatments for ZD (i.e. surgery, endoscopic stapling, CO2 laser treatment, FESD)
- presence of significant esophageal dysmotility disorder, such as achalasia
- presence of psychiatric comorbidities
- pregnancy
- failure to provide written consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name
Last name Kuwai
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure, Japan.
TEL +81-823-22-3111
Email kuwai.toshio.ur@mail.hosp.go.jp

Public contact
Name of contact person
1st name Toshio
Middle name
Last name Kuwai
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Gastroenterology
Zip code 737-0023
Address 3-1 Aoyama-cho, Kure, Japan.
TEL +81-823-22-3111
Homepage URL
Email kuwai.toshio.ur@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization NA
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 National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Address 3-1 Aoyama-cho, Kure 737-0023 Japan.
Tel +81-823-22-3111
Email kuwai.toshio.ur@mail.hosp.go.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
2019 Year 07 Month 20 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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 12 Day
Date of IRB
2019 Year 07 Month 12 Day
Anticipated trial start date
2019 Year 07 Month 13 Day
Last follow-up date
2024 Year 07 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
2019 Year 07 Month 12 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042574

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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