Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility Study of the Kronos Electrocautery Device

Conditions
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Hepatic Disease, Renal Disease

Intervention / Treatment
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* Device: Kronos Electrocautery Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., Patients have signed an informed consent Patients who are ≥ 18 years of age Exclusion Criteria: Patients with known bleeding disorder Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation. Active illness or active systemic infection or sepsis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The Kronos Electrocautery Device is a disposable electrocautery device that can cauterize deep tissue through a standard biopsy procedure guide needle. This device is intended to coagulate the tissue surrounding the core biopsy channel during withdrawal to reduce or eliminate significant post-procedural bleeding. Currently, the Kronos Electrocautery Device consists of one (1) size. As such, the existing Kronos Electrocautery Device is chosen as the worst-case condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys<br> | Device: Kronos Electrocautery Device<br>* The Kronos Electrocautery Device is a disposable electrocautery device that can cauterize deep tissue through a standard biopsy procedure guide needle. This device is intended to coagulate the tissue surrounding the core biopsy channel during withdrawal to reduce or eliminate significant post-procedural bleeding. Currently, the Kronos Electrocautery Device consists of one (1) size. As such, the existing Kronos Electrocautery Device is chosen as the worst-case condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Hematoma Formation | Patients will be contacted on day 14 post-procedure and asked a series of questions regarding Adverse Events related to the procedure. | 14 days | 
| Measure and Categorize Amount of Blood Loss From Biopsy Access Site | The weight of 10 gauze pads is taken prior to the procedure. Post-procedure, those same 10 gauze pads used at biopsy access site are weighed again to measure in grams, the amount of blood loss. The scale ranges from 1 (unacceptable) to 5 (excellent). | 1 hour post procedure | 
| Absence of the Need for Ultrasound Examination Due to Observation of Bleeding | Measuring the amount of patient who did not need an ultrasound examination due to observation of bleeding | 8 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Secondary Reintervention | Patients will be contacted on day 14 post-procedure and asked a series of questions regarding Adverse Events related to the procedure. Measuing the amount of patients who did not require secondary reintervention. | 14 days | 
| Time to Hospital Discharge |  | 8 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis, Liver Disease, Hepatic Disease