UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061249 |
|---|---|
| Receipt number | R000070086 |
| Scientific Title | Performance testing of a novel pacemaker pocket compression device |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 09:14:34 |
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Basic information
Public title
Performance testing of a novel pacemaker pocket compression device
Acronym
Performance testing of a novel pacemaker pocket compression device
Scientific Title
Performance testing of a novel pacemaker pocket compression device
Scientific Title:Acronym
Performance testing of a novel pacemaker pocket compression device
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pocket hematoma is a frequent early postoperative complication following the implantation of transvenous lead pacemakers. Furthermore, this complication serves as a primary precursor to pocket infection. Consequently, it is clinical convention to apply pocket compression for 24 to 48 hours post-procedure to mitigate this risk. To address this, we have developed a novel pocket compression device utilizing a leaf-spring mechanism. A multicenter randomized controlled trial (RCT) designed to demonstrate the clinical superiority of this device over the current standard of care has been accepted as a 2025 NHO (National Hospital Organization) Network Research project. Preceding this clinical study, verification of the device's compliance with design specifications is mandatory. To this end, we hereby propose a formal performance evaluation of the device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The compression pressures generated by leaf-spring-based device or compression bandage
2. participant-reported satisfaction.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The left infraclavicular skin is compressed with the leaf-spring-based device, and the interface pressure is measured.
Interventions/Control_2
The left infraclavicular skin is compressed with the compression bandage, and the interface pressure is measured.
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
Key inclusion criteria
Healthy male volunteers 18 years of age or older
Key exclusion criteria
1. Allergy to adhesive materials or polyurethan
2. Fragile skin
3. Marked kyphosis
4. Body weight greater than 120 kg
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Department of Cardiology
Zip code
739-0041
Address
Jike 513, Saijo-cho, Higashihiroshima City
TEL
0824232176
rjrgw059@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Department of Cardiology
Zip code
739-0041
Address
Jike 513, Saijo-cho, Higashihiroshima City
TEL
0824232176
Homepage URL
rjrgw059@ybb.ne.jp
Sponsor or person
Institute
National Hospital Organization Higashihiroshima Medical Center (Department of Clinical Research)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Higashihiroshima Medical Center (Department of Clinical Research)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Higashihiroshima Medical Center
Address
Jike 513, Saijo-cho, Higashihiroshima City
Tel
0824232176
rjrgw059@ybb.ne.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
広島県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 14 | 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
33
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
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070086
