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Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.

NCT05292326 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-09-22

No results posted yet for this study

Summary

PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation pocket hematoma. By avoiding a strong localized compression and ensuring "covering compression" achieved by the appropriate distribution of compression forces on the entire implantation site area, with an automated compression force control, the risk of a pressure sore created in the compressed pocket area is reduced.

Conditions

  • Hemorrhagic Complications
  • Hematoma
  • Hemorrhage
  • Pathologic Processes

Interventions

DEVICE

PacePress

an electronically-controlled compression site which, thanks to a well-selected compression force, may contribute significantly to preventing hemorrhagic complications following electrotherapy procedures, including to increasing safety of CIED implantation procedures and accelerate wound healing significantly

DEVICE

standard compression band

standard used compression band/sand bag

Sponsors & Collaborators

  • Medinice S.A.

    lead INDUSTRY

Principal Investigators

  • Przemysław Mitkowski, Prof. MD PhD · Medical University in Poznań

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05292326 on ClinicalTrials.gov