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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing a scheduled, elective, solid organ biopsy procedures on the liver or kidneys | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Time to Hospital Discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tahour, MD | Long Beach Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14694166 | Background | 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. | |
| 15458453 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The patients that completed the study. | Posted | Number | participants | 14 days |
|
14 days post proceedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trace Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Trace pneumothorax (right side) following biopsy & Kronos single pass use. Not characterized as procedure or device-related. Mild severity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy D. Ollerenshaw, Ph.D. | Anthem Biotechnologies | 770.337.2390 | ollerenj@anthembiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2022 | May 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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|
| 8 hours post procedure |
| 7210659 | Background | Mahal AS, Knauer CM, Gregory PB. Bleeding after liver biopsy. West J Med. 1981 Jan;134(1):11-4. |
| 28096727 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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). | Number of patients that completed the study | Posted | Median | Full Range | score on a scale | 1 hour post procedure |
|
|
|
| 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 | amount of patients completed the study | Posted | Number | participants | 8 hours post procedure |
|
|
|
| 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. | 30 patients that completed the study | Posted | Number | participants | 14 days |
|
|
|
| Secondary | Time to Hospital Discharge | Not Posted | 8 hours post procedure | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
|
| Shortness of breath and coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Notified at 14-day followup. Worsening shortness of breath after biopsy and coughing up pink sputum. Not characterized as procedure or device-related. Mild severity. No intervention was necessary. |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Notified at 14-day follow-up. Not characterized as device-related. Moderate severity. Pre-existing condition. |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | Notified at 14-day follow-up. Not characterized as device-related. Mild severity. Pain was present before biopsy due to metastatic disease of numerous organs. |
|
| Anasarca | Skin and subcutaneous tissue disorders | Systematic Assessment | Notified at 14-day follow-up. Not characterized as device-related. Mild severity. |
|
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| D052801 | Male Urogenital Diseases |