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CompletedNCT06144398Updated Aug 6, 2024

Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

An interventional study of Single Use Bronchoscope and Standard Bronchoscope in Atelectasis, Hemoptysis and Stridor, sponsored by Clinical Hospital Centre Zagreb. Completed at 1 site in Croatia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Clinical Hospital Centre Zagreb · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atelectasis
  • Hemoptysis
  • Stridor

Keywords

  • Bronchoscopy
  • Single Use Flexible Bronchoscope
  • Interventional Pulmonology
03

In context

Pulmonary Atelectasis

308 studies on the registry are indexed under Pulmonary Atelectasis; 79 are open to participants now.

This study's enrollment of 20 is below the median of 61 across 226 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Clinical Hospital Centre Zagreb is the lead sponsor of 32 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Single Use Bronchoscope

    Device: Single Use Bronchoscope

  • Active comparator
    Standard Bronchoscope

    Device: Standard Bronchoscope

Interventions

  • DeviceSingle Use Bronchoscope

    The interventional procedure is performed with a single use bronchoscope.

  • DeviceStandard Bronchoscope

    The interventional procedure is performed with a standard bronchoscope.

06

What researchers measure

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)

    Time frame: through study completion, an average of 12 months

Secondary outcomes

  1. 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)

    Time frame: through study completion, an average of 12 months

  2. Suction

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

    Time frame: through study completion, an average of 12 months

  3. Image quality

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

    Time frame: through study completion, an average of 12 months

  4. Bleeding control

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

    Time frame: through study completion, an average of 12 months

  5. 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)

    Time frame: through study completion, an average of 12 months

07

Study locations

1 site
  • University Hospital Centre Zagreb
    Zagreb, 10000, Croatia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06144398
Lead sponsor
Clinical Hospital Centre Zagreb
Responsible party
Goran Glodić (MD, Principal Investigator, Clinical Hospital Centre Zagreb) — Principal investigator
First posted
Nov 22, 2023
Start date
Nov 27, 2023
Primary completion
Mar 29, 2024
Completion
Mar 29, 2024
Last update
Aug 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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