N/A
Completed N=31
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
Hepatic Disease · Renal disease
Source: ClinicalTrials.gov NCT05593211 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Absence of Hematoma Formation — 30 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Hematoma Formation |
30 | — |
| PRIMARY Measure and Categorize Amount of Blood Loss From Biopsy Access Site |
5.0 | — |
| PRIMARY Absence of the Need for Ultrasound Examination Due to Observation of Bleeding |
30 | — |
| SECONDARY Absence of Secondary Reintervention |
30 | — |
| SECONDARY Time to Hospital Discharge |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05593211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.