Hepatic Disease, Renal Disease
Conditions
Keywords
Hepatitis, Liver Disease, Hepatic Disease
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.
Interventions
DEVICEKronos 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
Sponsors
Single Pass Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., 2. Patients have signed an informed consent 3. Patients who are ≥ 18 years of age
Exclusion criteria
1. Patients with known bleeding disorder 2. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 3. Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation. 4. Active illness or active systemic infection or sepsis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Hematoma Formation | 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 | 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 | 8 hours post procedure | Measuring the amount of patient who did not need an ultrasound examination due to observation of bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Secondary Reintervention | 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. |
| Time to Hospital Discharge | 8 hours post procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 14 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Age, Continuous | 59 years STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 31 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 14 days
Population: The patients that completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys | Absence of Hematoma Formation | 30 participants |
Primary
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
Time frame: 8 hours post procedure
Population: amount of patients completed the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys | Absence of the Need for Ultrasound Examination Due to Observation of Bleeding | 30 participants |
Primary
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).
Time frame: 1 hour post procedure
Population: Number of patients that completed the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys | Measure and Categorize Amount of Blood Loss From Biopsy Access Site | 5.0 score on a scale |
Secondary
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 frame: 14 days
Population: 30 patients that completed the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Undergoing a Scheduled, Elective, Solid Organ Biopsy Procedures on the Liver or Kidneys | Absence of Secondary Reintervention | 30 participants |
Secondary
Time to Hospital Discharge
Time frame: 8 hours post procedure