UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024522 |
|---|---|
| Receipt number | 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 | 2021/10/26 14:25:06 |
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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
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
yajimatos@yahoo.co.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 09 | Day |
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
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028102
