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Low Thermal Electrosurgical Device for Atraumatic Internal Thoracic Artery Harvesting

NCT03510026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-04-27

No results posted yet for this study

Summary

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated discharge along an insulated electrode, creating a cutting edge while the blade stays near body temperature. The aim of this study is to compare the histological samples, cardiac computed-tomography of graft patency, and clinical outcomes of patients after off-pump coronary artery bypass grafting with preparation of the internal thoracic arteries by a conventional electrosurgical device and the PlasmaBlade.

Conditions

  • Preparation of Internal Thoracic Artery

Interventions

DEVICE

Low thermal device preparation

One participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.

Sponsors & Collaborators

  • Triemli Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-08
Primary Completion
2014-04-01
Completion
2014-10-01

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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 NCT03510026 on ClinicalTrials.gov