Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061249) titled 'Performance testing of a novel pacemaker pocket compression device' on April 14.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - National Hospital Organization Higashihiroshima Medical Center (Department of Clinical Research)

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070086

Disclaimer: Curated by HT Syndication.