UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029341 |
|---|---|
| Receipt number | R000033534 |
| Scientific Title | A Japanese, single-center, open-label, prospective, safety study of AT-04 in healthy people |
| Date of disclosure of the study information | 2017/10/03 |
| Last modified on | 2018/02/14 17:34:27 |
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Basic information
Public title
A Japanese, single-center, open-label, prospective, safety study of AT-04 in healthy people
Acronym
A Japanese, single-center, open-label, prospective, safety study of AT-04 in healthy people
Scientific Title
A Japanese, single-center, open-label, prospective, safety study of AT-04 in healthy people
Scientific Title:Acronym
A Japanese, single-center, open-label, prospective, safety study of AT-04 in healthy people
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of long-time use of AT-04 in healthy subject.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events, adverse reactions which are related to or undeniable to study treatment, and their frequencies.
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
(1) AT-04
AT-04 is an investigational medical device (unapproved) that concurrently produces magnetic fields (2 kHz and 83.3 MHz) to relieve pain.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Age: Patients aged 20 years of age or older - <80 years (healthy adult at the time of obtaining informed consent)
(2) Patients from whom written informed consent can be directly obtained
Key exclusion criteria
(1) Patients with expected survival less than 3 years due to malignancies or other reasons
(2) Patients using life-sustaining electrical medical devices, such as artificial heart-lung devices
(3) Patients using affixed electrical medical devices, such as ECG recorders
(4) Patients who are participating in another clinical trial for a pharmaceutical product or medical device
(5) Patients with dementia that seriously disturbs activities of daily life
(6) Females who wish to become pregnant or are presently pregnant or nursing mothers (if the patient is a woman of childbearing potential, a pregnancy test must be performed)
and others.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwao Kishita |
Organization
PEACE OF MIND Co., Ltd.
Division name
President
Zip code
Address
3-37-24, Takahira, Kita-ku, Kumamoto City, Kumamoto, 860-0085 JAPAN
TEL
096-345-6600
kishita.2011.1.11@p-mind.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | In Guto |
Organization
Japanese Organization for Medical Device Development, Inc.
Division name
COO
Zip code
Address
#601, 2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023 JAPAN
TEL
03-6262-3322
Homepage URL
pm@jomdd.com
Sponsor or person
Institute
PEACE OF MIND Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
PEACE OF MIND Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 05 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
