The Primary Objective for This Study is to Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following a Biopsy Procedure in the Liver or Kidney

• Sponsor: Single Pass Inc (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05593211
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief Summary

This is a clinical study designed to evaluate the performance of the Kronos Electrocautery Device used to reduce or prevent bleeding following a biopsy procedure in the liver and kidney.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Disease; Renal Disease	Device: Kronos Electrocautery Device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Supportive Care
• Official Title: Feasibility Study of the Kronos Electrocautery Device
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Jan 15, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

1. Absence of Hematoma formation [14 days]

2. Measure and categorize amount of blood loss from biopsy access site [1 hour post procedure]

3. Absence of the need for ultrasound examination due to observation of bleeding [8 hours post procedure]

Secondary Outcome Measures

1. Absence of secondary reintervention [14 days]

2. Time to hospital discharge [8 hours post procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Single Pass Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Single Pass Inc
• ClinicalTrials.gov Identifier: NCT05593211
• Other Study ID Numbers: SP-01
• First Posted: Oct 25, 2022
• Last Update Posted: Oct 25, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Single Pass Inc: Hepatitis; Liver Disease; Hepatic Disease
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Oct 25, 2022