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Completed

NCT Number: NCT05593211

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

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.

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Key information

Conditions

Hepatic Disease Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatitis Kidney Diseases Liver Diseases Male Urogenital Diseases Renal Disease Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Absence of Hematoma Formation

    Time frame: 14 days

    Patients will be contacted on day 14 post-procedure and asked a series of questions regarding Adverse Events related to the procedure.

  2. Measure and Categorize Amount of Blood Loss From Biopsy Access Site

    Time frame: 1 hour post procedure

    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).

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

    Time frame: 8 hours post procedure

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

Secondary outcomes

  1. Absence of Secondary Reintervention

    Time frame: 14 days

    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.

  2. Time to Hospital Discharge

    Time frame: 8 hours post procedure

Sponsors and collaborators

Lead sponsor

Single Pass Inc

Industry

Registry information

Official study title

Feasibility Study of the Kronos Electrocautery Device

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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