Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

NCT06144398 | Completed

• 1 other identifier: 8.1-22/21-2; 02/013AG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis; Hemoptysis; Stridor

Keywords

Bronchoscopy; Single Use Flexible Bronchoscope; Interventional Pulmonology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functionality, handle and interface

  through study completion, an average of 12 months

• Suction

  through study completion, an average of 12 months

• Image quality

  through study completion, an average of 12 months

• Bleeding control

  through study completion, an average of 12 months

• Compatibility

  through study completion, an average of 12 months

Study Arms (2)

Single Use Bronchoscope

EXPERIMENTAL

Device: Single Use Bronchoscope

Standard Bronchoscope

ACTIVE COMPARATOR

Device: Standard Bronchoscope

Interventions

Single Use Bronchoscope DEVICE

The interventional procedure is performed with a single use bronchoscope.

Single Use Bronchoscope

Standard Bronchoscope DEVICE

The interventional procedure is performed with a standard bronchoscope.

Standard Bronchoscope

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring an interventional pulmonary procedure during the study period
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Hemoptysis; Respiratory Sounds

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: November 27, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CR (1)