Hepatic DiseaseNCT05593211

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

A study testing Kronos Electrocautery Device in people with Hepatic Disease and Renal Disease, run by Single Pass Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Disease, Renal Disease
What is being tested?: Kronos Electrocautery Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2022to 9 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Long Beach Memorial Medical Center
Long Beach, California, 90806

Other trials in United States

About this study

Official title: Feasibility Study of the Kronos Electrocautery Device

Read the 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.

Conditions: Hepatic Disease, Renal Disease
Being tested: Kronos Electrocautery Device
Keywords: Hepatitis, Liver Disease, Hepatic Disease
Medical subject headings: Digestive System Diseases, Kidney Diseases, Hepatitis, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kronos Electrocautery DeviceDevice
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 groups in NCT05593211
Study group	Role	What they receive
Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys	Experimental	Not described Receives: Device: Kronos Electrocautery Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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
Measured: 8 hours post procedure

Secondary outcomes (2)

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.
Measured: 14 days
Time to Hospital Discharge
Measured: 8 hours post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 20229 Feb 2023

First posted25 Oct 2022
Study start17 Oct 2022
Primary completion9 Feb 2023
Study completion9 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hepatic DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05593211
Sponsor's protocol ID: SP-01
Status last verified: Jun 2023
First submitted: 19 Aug 2022
Last updated: 27 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 14694166
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.
PubMed 15458453
Mahal AS, Knauer CM, Gregory PB. Bleeding after liver biopsy. West J Med. 1981 Jan;134(1):11-4.
PubMed 7210659
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.
PubMed 28096727

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of the Kronos Electrocautery Device
ClinicalTrials.gov ID: NCT05593211
Acronym / sponsor ID: SP-01
Conditions: Hepatic Disease, Renal Disease
Keywords: Hepatitis, Liver Disease, Hepatic Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Single Pass IncIndustry (pharma, biotech, devices)
Study start: 17 Oct 2022 (actual)
Primary completion: 9 Feb 2023 (actual)
Study completion: 9 Feb 2023 (actual)
First posted: 25 Oct 2022 (actual)
Results: Posted 27 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys	Experimental	Device: Kronos Electrocautery Device

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kronos Electrocautery DeviceThe 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	Device	Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys

Primary outcome

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.
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).
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

2 secondary outcomes

Absence of Secondary Reintervention
Time frame: 14 days
Time to Hospital Discharge
Time frame: 8 hours post procedure

Results and safety

Results posted to the registry on 27 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys	31	30

Primary outcome: Absence of Hematoma Formation

Time frame: 14 days. Number. Unit: participants

Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n = 30
Value	30

Population analysed: The patients that completed the study.

Primary outcome: Measure and Categorize Amount of Blood Loss From Biopsy Access Site

Time frame: 1 hour post procedure. Median (Full Range). Unit: score on a scale

Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n = 30
Value	5.0 (1 to 5)

Population analysed: Number of patients that completed the study

Primary outcome: Absence of the Need for Ultrasound Examination Due to Observation of Bleeding

Time frame: 8 hours post procedure. Number. Unit: participants

Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n = 30
Value	30

Population analysed: amount of patients completed the study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days post proceedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14694166Whittier 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.
Background: PubMed 15458453Manno 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.
Background: PubMed 7210659Mahal AS, Knauer CM, Gregory PB. Bleeding after liver biopsy. West J Med. 1981 Jan;134(1):11-4.
Background: PubMed 28096727Lim 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Tahour, MD principal investigator

Long Beach Memorial Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Kronos Electrocautery Device in people with Hepatic Disease and Renal Disease, run by Single Pass Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of Hematoma Formation (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05593211, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.