Trial Outcomes & Findings for Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures (NCT NCT05593211)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

14 days

Results posted on

2023-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys 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
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys 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
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=31 Participants 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
Age, Categorical <=18 years	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=31 Participants
Age, Categorical >=65 years	14 Participants n=31 Participants
Age, Continuous	59 years STANDARD_DEVIATION 15 • n=31 Participants
Sex: Female, Male Female	18 Participants n=31 Participants
Sex: Female, Male Male	13 Participants n=31 Participants
Region of Enrollment United States	31 participants n=31 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The patients that completed the study.

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

Outcome measures

Outcome measures
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=30 Participants 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
Absence of Hematoma Formation	30 participants

PRIMARY outcome

Timeframe: 1 hour post procedure

Population: Number of patients that completed the study

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).

Outcome measures

Outcome measures
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=30 Participants 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
Measure and Categorize Amount of Blood Loss From Biopsy Access Site	5.0 score on a scale Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 8 hours post procedure

Population: amount of patients completed the study

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

Outcome measures

Outcome measures
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=30 Participants 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
Absence of the Need for Ultrasound Examination Due to Observation of Bleeding	30 participants

SECONDARY outcome

Timeframe: 14 days

Population: 30 patients that completed the study

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.

Outcome measures

Outcome measures
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=30 Participants 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
Absence of Secondary Reintervention	30 participants

SECONDARY outcome

Timeframe: 8 hours post procedure

Outcome measures

Outcome data not reported

Adverse Events

Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys n=30 participants at risk 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
Respiratory, thoracic and mediastinal disorders Trace Pneumothorax	3.3% 1/30 • Number of events 1 • 14 days post proceedure
Respiratory, thoracic and mediastinal disorders Shortness of breath and coughing	3.3% 1/30 • Number of events 1 • 14 days post proceedure
Respiratory, thoracic and mediastinal disorders Shortness of breath	3.3% 1/30 • Number of events 1 • 14 days post proceedure
Gastrointestinal disorders Abdominal Pain	3.3% 1/30 • Number of events 1 • 14 days post proceedure
Skin and subcutaneous tissue disorders Anasarca	3.3% 1/30 • Number of events 1 • 14 days post proceedure

Additional Information

Jeremy D. Ollerenshaw, Ph.D.

Anthem Biotechnologies

Phone: 770.337.2390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place