UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028001
Receipt number 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 17:05:25

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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 or person

Institute

Graduate School of Medicine Kyoto University

Institute

Department

Personal name



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

Value
https://center6.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