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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06144398
Other study ID # 8.1-22/21-2; 02/013AG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2023
Est. completion date November 2024

Study information

Verified date December 2023
Source Clinical Hospital Centre Zagreb
Contact Sonja Badovinac, MD, PhD
Phone 00385(1)2385129
Email sonjabadovinac1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - All patients requiring an interventional pulmonary procedure during the study period - Signed informed consent Exclusion Criteria: - Any patient with a contraindication for rigid and/or flexible bronchoscopy - Coagulopathy (PV INR > 1.3) - Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L) - DOAC, LMWH or antiplatelet drug therapy - Thrombophilia, history of pulmonary embolism or deep vein thrombosis - Contraindication for endobronchial application of adrenaline - Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia - Uncontrolled pulmonary hypertension - Cardiovascular decompensation - Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%) - Cervical spine instability

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Single Use Bronchoscope
The interventional procedure is performed with a single use bronchoscope.
Standard Bronchoscope
The interventional procedure is performed with a standard bronchoscope.

Locations

Country Name City State
Croatia University Hospital Centre Zagreb Zagreb

Sponsors (1)

Lead Sponsor Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall performance Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
Secondary Functionality, handle and interface Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
Secondary Suction Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
Secondary Image quality Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
Secondary Bleeding control Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
Secondary Compatibility Compatibility with other devices (i.e. ballon blockers, forceps, laser, cryprobe) as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) through study completion, an average of 12 months
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