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

NCT05593211 | Completed Results FDA Device

• 1 other identifier: SP-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Disease; Renal Disease

Keywords

Hepatitis; Liver Disease; Hepatic Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Absence of Secondary Reintervention

  14 days

• Time to Hospital Discharge

  8 hours post procedure

Study Arms (1)

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

EXPERIMENTAL

Device: Kronos Electrocautery Device

Interventions

Kronos Electrocautery Device 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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Single Pass Inc: lead

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Related Publications (4)

• 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.

  PMID: 14694166 BACKGROUND

• 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.

  PMID: 15458453 BACKGROUND

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

  PMID: 7210659 BACKGROUND

• 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.

  PMID: 28096727 BACKGROUND

MeSH Terms

Conditions

Digestive System Diseases; Kidney Diseases; Hepatitis; Liver Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jeremy D. Ollerenshaw, Ph.D.
• Organization: Anthem Biotechnologies

ollerenj@anthembiotech.com

770.337.2390

Study Officials

• David Tahour, MD

  Long Beach Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: October 25, 2022
• Study Start: October 17, 2022
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)