Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

• Sponsor: Clinical Hospital Centre Zagreb (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06144398
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atelectasis; Hemoptysis; Stridor	Device: Single Use Bronchoscope; Device: Standard Bronchoscope	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Use Bronchoscope	Device: Single Use Bronchoscope; The interventional procedure is performed with a single use bronchoscope.
Active Comparator: Standard Bronchoscope	Device: Standard Bronchoscope; The interventional procedure is performed with a standard bronchoscope.

Outcome Measures

Primary Outcome Measures

1. Overall performance [through study completion, an average of 12 months]

   Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

Secondary Outcome Measures

1. Functionality, handle and interface [through study completion, an average of 12 months]

   Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

2. Suction [through study completion, an average of 12 months]

   Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

3. Image quality [through study completion, an average of 12 months]

   Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

4. Bleeding control [through study completion, an average of 12 months]

   Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

5. Compatibility [through study completion, an average of 12 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Centre Zagreb	Zagreb		Croatia	10000

Sponsors and Collaborators

• Clinical Hospital Centre Zagreb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Goran Glodić, MD, Principal Investigator, Clinical Hospital Centre Zagreb
• ClinicalTrials.gov Identifier: NCT06144398
• Other Study ID Numbers: 8.1-22/21-2; 02/013AG
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Goran Glodić, MD, Principal Investigator, Clinical Hospital Centre Zagreb: Bronchoscopy; Single Use Flexible Bronchoscope; Interventional Pulmonology
• Additional relevant MeSH terms: Pulmonary Atelectasis; Hemoptysis

Study Results

No Results Posted as of Nov 22, 2023