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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011080
Receipt No. R000012970
Scientific Title Robotic surgery for Achalasia
Date of disclosure of the study information 2013/06/30
Last modified on 2016/07/01

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Basic information
Public title Robotic surgery for Achalasia
Acronym Robotic surgery for Achalasia
Scientific Title Robotic surgery for Achalasia
Scientific Title:Acronym Robotic surgery for Achalasia
Region
Japan

Condition
Condition Achalasia
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficiency of robotic surgery for achalasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety and efficiency
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 Robotic surgery
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Esophageal achalasia
2. Age: 20 and more, 79 or younger.
3.Performance Status (ECOG):0 or1
4.At least 4 weeks has been past since previous treatments
5.Appropriate organ functions are preserved.
Key exclusion criteria 1. Obvious infection
2. Severe hypo alimentation
3. Uncontrorable pleural effusion, ascites, pericardial effusion
4. Severe heart failure
5. Severe complication
6. Psychiatric disorders
7. Active cancers
8. Steroid usage
9. Hepatitis, HIV positive, HTLV-1 Positive
10. Hyper sensitivity for albumin
11. Pregnant woman
12. Autoimmune diseases
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University
Division name Department of GI-Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba
TEL 043-222-7171
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Akutsu
Organization Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba
TEL 043-226-2110
Homepage URL
Email yakutsu@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2013 Year 06 Month 30 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 Completed
Date of protocol fixation
2012 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 30 Day
Last modified on
2016 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012970

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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