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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024522
Receipt No. R000028102
Scientific Title A clinical study for evaluating the safety of video assisted thoracic surgery for mediastinal diseases using sternal lifting by subcutaneous stabbing Kurschner wire
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/21

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Basic information
Public title A clinical study for evaluating the safety of video assisted thoracic surgery for mediastinal diseases using sternal lifting by subcutaneous stabbing Kurschner wire
Acronym A clinical study for evaluating the safety of video assisted thoracic surgery for mediastinal diseases using sternal lifting by subcutaneous stabbing Kurschner wire
Scientific Title A clinical study for evaluating the safety of video assisted thoracic surgery for mediastinal diseases using sternal lifting by subcutaneous stabbing Kurschner wire
Scientific Title:Acronym A clinical study for evaluating the safety of video assisted thoracic surgery for mediastinal diseases using sternal lifting by subcutaneous stabbing Kurschner wire
Region
Japan

Condition
Condition mediastinal diseases
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of sternal lifting method by subcutaneous stabbing Kurschner wire for the purpose of obtained surgical working space in video assisted thoracic surgery for mediastinal diseases.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical safety(Subjective symptoms, Objective symptoms)
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
Device,equipment
Interventions/Control_1 To evaluate the safety of sternal lifting method by subcutaneous stabbing Kurschner wire for the purpose of obtained surgical working space in video assisted thoracic surgery for mediastinal diseases.
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 1)Men and women aged more than 20 years old.
2)The patients with anterior mediastinal tumor or MG
3)No sing of tumor invasion to sounding tissue by image
4)No limitation of tumor diameter
5)ECOG performance status 0 or 1
6)Patients who are able to tolerate the surgery
7)Patients must have sufficient organ function
8)Patients who understand details of the study and provides informed consent by documents.
Key exclusion criteria 1)Medical history with surgery of median sternotomy
2)Patients with operative wound in anterior chest
3)patients regarded as ineligible by principal investigator or researcher
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Mogi
Organization Gunma University Graduate School of Medicine
Division name Division General Thoracic Surgery
Zip code
Address 3-39-22 Showa-machi, Maebashi,Gunma,Japan
TEL 027-220-8224
Email akmogi@gunma-u.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Yajima
Organization Gunma University Graduate School of Medicine
Division name Division General Thoracic Surgery
Zip code
Address 3-39-22 Showa-machi, Maebashi,Gunma,Japan
TEL 027-220-8224
Homepage URL
Email yajimatos@yahoo.co.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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
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
2016 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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
2016 Year 10 Month 21 Day
Last modified on
2016 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028102

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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