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

Renal Disease Clinical Trial

Official title:

Feasibility Study of the Kronos Electrocautery Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593211
• Other study ID #: SP-01
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: February 9, 2023

Study information

• Verified date: June 2023
• Source: Single Pass Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Disease
• Liver Diseases
• Renal Disease

Intervention

Device:
• Kronos Electrocautery Device
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

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Single Pass Inc

Country where clinical trial is conducted

United States, 

References & Publications (4)

Lim S, Rhim H, Lee MW, Song KD, Kang TW, Kim YS, Lim HK. New Radiofrequency Device to Reduce Bleeding after Core Needle Biopsy: Experimental Study in a Porcine Liver Model. Korean J Radiol. 2017 Jan-Feb;18(1):173-179. doi: 10.3348/kjr.2017.18.1.173. Epub 2017 Jan 5. — View Citation

Mahal AS, Knauer CM, Gregory PB. Bleeding after liver biopsy. West J Med. 1981 Jan;134(1):11-4. — View Citation

Manno C, Strippoli GF, Arnesano L, Bonifati C, Campobasso N, Gesualdo L, Schena FP. Predictors of bleeding complications in percutaneous ultrasound-guided renal biopsy. Kidney Int. 2004 Oct;66(4):1570-7. doi: 10.1111/j.1523-1755.2004.00922.x. — View Citation

Whittier WL, Korbet SM. Timing of complications in percutaneous renal biopsy. J Am Soc Nephrol. 2004 Jan;15(1):142-7. doi: 10.1097/01.asn.0000102472.37947.14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Time to Hospital Discharge		8 hours post procedure