UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043143 |
|---|---|
| Receipt number | R000049183 |
| Scientific Title | Post-market surveillance of NeuRx Diaphragm Pacing System for patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve |
| Date of disclosure of the study information | 2021/01/27 |
| Last modified on | 2023/06/30 15:59:04 |
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Basic information
Public title
Post-market surveillance of NeuRx Diaphragm Pacing System for patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve
Acronym
Post-market surveillance of NeuRx Diaphragm Pacing System
Scientific Title
Post-market surveillance of NeuRx Diaphragm Pacing System for patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve
Scientific Title:Acronym
Post-market surveillance of NeuRx Diaphragm Pacing System
Region
| Japan |
Condition
Condition
The patients with spinal cord injury (cervical) and central hypoventilation syndrome dependent on mechanical ventilation that allow diaphragmatic contraction by electrical stimulation of the phrenic nerve
Classification by specialty
| Pneumology | Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect and confirm information on the efficacy and safety under real world usage of NeuRx Diaphragm Pacing System in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Safety>
Occurrence rate of adverse events and malfunctions of the device
<Efficacy>
1) Tidal volume acquired by using NeuRx
2) Continuous use time and long-term use of NeuRx
Key secondary outcomes
<Efficacy>
1) Maintaining or improving diaphragmatic function
2) Maintaining oxygen saturation by using NeuRx
3) Improved QOL by using NeuRx
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who were registered in the post market surveillance of NeuRx Diaphragm Pacing System
Key exclusion criteria
Not applicable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kuwabara |
Organization
USCI Japan, Ltd.
Division name
Business Planning and Development Department
Zip code
151-0053
Address
Ichigo Nishisando Bldg. 4F 3-28-6 Yoyogi, Shibuya-ku, Tokyo 151-0053 Japan
TEL
03-6823-1100
yuki_kuwabara@usci.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kuwabara |
Organization
USCI Japan, Ltd.
Division name
Business Planning and Development Department
Zip code
151-0053
Address
Ichigo Nishisando Bldg. 4F 3-28-6 Yoyogi, Shibuya-ku, Tokyo 151-0053 Japan
TEL
03-6823-1100
Homepage URL
yuki_kuwabara@usci.co.jp
Sponsor or person
Institute
USCI Japan, Ltd.
Institute
Department
Personal name
Funding Source
Organization
USCI Japan, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Medical Society of Spinal Cord Lesion
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2021 | Year | 01 | Month | 27 | 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
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) This survey is an all-case survey.
2) This survey does not require the approval of IRB because of Post- market surveillance.
<CCHS>
Dec. 2020 1st case registration
Sep. 2021 2nd case registration
Jul. 2022 3rd case registration
Jan. 2023 4th case registration
May. 2023 5th case registration
<SCI>
Jan. 2021 1st case registration
<ACHS>
Aug. 2022 1st case registration
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
