UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004808
Receipt number R000005725
Scientific Title A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases
Date of disclosure of the study information 2010/12/30
Last modified on 2010/12/30 14:20:38

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases

Acronym

Measurement of lymphatic pumping pressure in human extremities.

Scientific Title

A study of human lymphatic pumping pressure in human extremities - role of aging, life style and various diseases

Scientific Title:Acronym

Measurement of lymphatic pumping pressure in human extremities.

Region

Japan


Condition

Condition

healthy volunteers, patients with lymph edema and patients with varisou diseases

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effect of aging, life style, and lymph edema on human lymphatic pumping in extremities.

Basic objectives2

Others

Basic objectives -Others

Observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lymph pumping pressure in extremities.
Assessment of quality of life with SF-36

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

volunteers

Key exclusion criteria

iodine allergy

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Unno

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu

TEL

053-435-2279

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoki Unno

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code


Address


TEL


Homepage URL


Email

unno@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu Universtiy School of Medicine

Organization

Division

Category of Funding Organization

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

2010 Year 12 Month 30 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

Open public recruiting

Date of protocol fixation

2009 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

measurement of lymphatic pumping pressure.
Assessment with SF-36


Management information

Registered date

2010 Year 12 Month 30 Day

Last modified on

2010 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name