UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of a new navigation system for aortic vascular surgery
Title of the study (Brief title)	Clinical evaluation of a new navigation system for aortic vascular surgery
Region	Japan

Condition
Condition	Descending thoracic and thoracoabdominal aortic aneurysm
Classification by specialty	Surgery in general Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Improvement of target registration accuracy by using a new registration algorithm
Basic objectives2	Others
Basic objectives -Others	Evaluation of system performance and operation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fiducial localization error (FLE) and target registration error (TRE) in anatomical landmarks
Key secondary outcomes	-Identification of a target intercostal artery -Length of time required to perform a surgical navigation system -System error -Surgeon questionnaire -Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Supporting a surgeon's decision to identify a target intercostal artery by a navigation system during 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with descending/thoracoabdominal aortic aneurysm 2)Patients indicated for surgery for aortic aneurysm or aortic dissection at Tokyo Women's Medical University 3)Obtaining informed consent for participant
Key exclusion criteria	1)An inadequate case judged by a head of research 2)Emergent operation 3)Patients unfit for aortic surgery
Target sample size	15

Research contact person
Name of lead principal investigator	Kenji Yamazaki
Organization	Tokyo Women's Medical University
Division name	Department of Cardiovascular Surgery
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	syamazak@hij.twmu.ac.jp

Public contact
Name of contact person	Shigeyuki Aomi
Organization	Tokyo Women's Medical University
Division name	Department of Cardiovascular Surgery
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	saomi@hij.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Waseda University, National Institute of Health Sciences
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	東京女子医科大学（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 18 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2016 Year 01 Month 23 Day
Anticipated trial start date	2016 Year 04 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	2016 Year 03 Month 17 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024776