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

Primary Purpose

Hepatic Disease, Renal Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Kronos Electrocautery Device

About this trial

This is an interventional supportive care trial for Hepatic Disease focused on measuring Hepatitis, Liver Disease, Hepatic Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

Long Beach Memorial Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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.

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).

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

Secondary Outcome Measures

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 to Hospital Discharge

Full Information

NCT ID

NCT05593211

First Posted

August 19, 2022

Last Updated

June 2, 2023

Sponsor

Single Pass Inc

1. Study Identification

Unique Protocol Identification Number

NCT05593211

Brief Title

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

Official Title

Feasibility Study of the Kronos Electrocautery Device

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 17, 2022 (Actual)

Primary Completion Date

February 9, 2023 (Actual)

Study Completion Date

February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Single Pass Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Disease, Renal Disease

Keywords

Hepatitis, Liver Disease, Hepatic Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Kronos Electrocautery Device

Intervention Description

Primary Outcome Measure Information:

Title

Absence of Hematoma Formation

Description

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

Title

Measure and Categorize Amount of Blood Loss From Biopsy Access Site

Description

Time Frame

1 hour post procedure

Title

Absence of the Need for Ultrasound Examination Due to Observation of Bleeding

Description

Measuring the amount of patient who did not need an ultrasound examination due to observation of bleeding

Time Frame

8 hours post procedure

Secondary Outcome Measure Information:

Title

Absence of Secondary Reintervention

Description

Time Frame

14 days

Title

Time to Hospital Discharge

Time Frame

8 hours post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Tahour, MD

Organizational Affiliation

Long Beach Memorial Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Long Beach Memorial Medical Center

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14694166

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.

Results Reference

background

PubMed Identifier

15458453

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.

Results Reference

background

PubMed Identifier

7210659

Citation

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

Results Reference

background

PubMed Identifier

28096727

Citation

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.

Results Reference

background

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

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