UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028102