UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041431 |
|---|---|
| Receipt number | R000047263 |
| Scientific Title | Flexible endoscopic septum division for Zenker's diverticulum: Multicenter prospective study. |
| Date of disclosure of the study information | 2020/08/24 |
| Last modified on | 2024/08/29 18:20:39 |
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Basic information
Public title
Flexible endoscopic septum division for Zenker's diverticulum: Multicenter prospective study.
Acronym
FESD for ZD
Scientific Title
Flexible endoscopic septum division for Zenker's diverticulum: Multicenter prospective study.
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
Complication rate
Recurrence rate
Shape of diverticulum
Dysphagia score
Procedure time
Hospitalization
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-PS 1-2.
- Written informed consent.
Key exclusion criteria
- previous upper gastrointestinal surgery.
- previous treatment for ZD(i.e. surgery, endoscopic stapling, CO2 laser treatment, FESD).
- presence of significant esophageal dysmotility disorder, such as achalasia.
- presence of severe complication.
- 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
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
kuwai.toshio.ur@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
N/A
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, Japan
Tel
+81-823-22-3111
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
| 2020 | Year | 08 | Month | 24 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047263
