UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034666
Receipt No. R000038415
Official scientific title of the study Endoscopic diverculectomy for Zenker diverticulum -multicenter study-
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Endoscopic diverculectomy for Zenker diverticulum -multicenter study-
Title of the study (Brief title) 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 Shuji Terai
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-227-2207
Email terais@med.niigata-u.ac.jp

Public contact
Name of contact person Hiroki Sato
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Division of Gastroenterology and Hepatology
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-227-2207
Homepage URL
Email pyloki-sato@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 17 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.