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

Single Pass Inc31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hepatic Disease Renal Disease

Interventions

Kronos Electrocautery DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., 2. Patients have signed an informed consent 3. Patients who are ≥ 18 years of age Exclusion Criteria: 1. Patients with known bleeding disorder 2. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 3. Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation. 4. Active illness or active systemic infection or sepsis.

Locations (1)

Long Beach Memorial Medical Center

Long Beach, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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

Time frame: 8 hours post procedure

Secondary Outcomes

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.

Time frame: 14 days

Time to Hospital Discharge

Time frame: 8 hours post procedure

Data from ClinicalTrials.gov

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