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Feasibility Study of the Kronos Electrocautery Device
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.
The Kronos Electrocautery Device is intended to be used in electrocautery procedures to control bleeding by use of electrical current to heat the device probe tip that is applied directly to the target tissue area of treatment. Prospective, multi-center, single-arm study with consecutive, eligible subject enrollment at each site. Patients who require a coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., will be eligible to participate in this study.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
Yes
Long Beach Memorial Medical Center
Long Beach, California, United States
Start Date
October 17, 2022
Primary Completion Date
February 9, 2023
Completion Date
February 9, 2023
Last Updated
June 27, 2023
31
ACTUAL participants
Kronos Electrocautery Device
DEVICE
Lead Sponsor
Single Pass Inc
NCT04634916
NCT06933472
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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