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

Single Pass

Status: Completed

Conditions: Renal Disease; Hepatic Disease

Treatments: Device: Kronos Electrocautery Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05593211

SP-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys

Experimental group

Treatment:

Device: Kronos Electrocautery Device