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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028001
Receipt No. R000032067
Scientific Title An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Date of disclosure of the study information 2017/09/14
Last modified on 2019/03/13

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Basic information
Public title An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Acronym An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Scientific Title An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Scientific Title:Acronym An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Region
Japan

Condition
Condition Patients who are scheduled for anterolateral thigh free flap surgery
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the cutaneous and subcutaneous blood vessel network using photoacoustic imaging
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Imaging capability of the photoacoustic imaging system for blood vessels in the extremities
Key secondary outcomes Incidence of adverse events by using the photoacoustic imaging system
(Final monitoring is conducted within 90 days after intervention)

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Photoacoustic Imaging
(Duration of the device use is for one day)
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 who are scheduled for anterolateral thigh free flap surgery
2. Patients who aged over 20 years and older at the time of informed consent
3. Patients who have agreed to participate in this study from their own free will with document consents
Key exclusion criteria 1. Pregnant and lactating patients
2. Patients who takes photosensitizer for photodynamic therapy
3. Patients with a cardiac pacemaker
4. Patients with greater than or equal to class 4 (Patients with severe systemic disease that is a constant threat to life)
in ASA-PS (American Society of Anaesthesiologists physical status classification)
5. People who have any following complications
Infections of the evaluation region
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position
6. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Susumu
Middle name
Last name Saito
Organization Graduate School of Medicine Kyoto University
Division name Plastic and Reconstructive Surgery
Zip code 606-8507
Address 54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL 075-751-3613
Email prs@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Itaru
Middle name
Last name Tsuge
Organization Graduate School of Medicine Kyoto University
Division name Plastic and Reconstructive Surgery
Zip code 606-8507
Address 54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL 075-751-3613
Homepage URL
Email prs@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Cabinet Office (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Canon Inc.
Hitachi, Ltd.
Name of secondary funder(s) Canon Inc.
Hitachi, Ltd.

IRB Contact (For public release)
Organization Kyoto University Hospital Ethics Committe
Address Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel 0757534680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2017 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 9
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
2017 Year 06 Month 14 Day
Date of IRB
2017 Year 09 Month 11 Day
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032067

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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