AtelectasisNCT06144398
Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures
A study testing Single Use Bronchoscope and Standard Bronchoscope in people with Atelectasis and Hemoptysis, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atelectasis, Hemoptysis, Stridor
- What is being tested?
- Single Use Bronchoscope and Standard Bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- 27 Nov 2023to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring an interventional pulmonary procedure during the study period
- Signed informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial
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
- Being tested
- Single Use Bronchoscope, Standard Bronchoscope
- Keywords
- Bronchoscopy, Single Use Flexible Bronchoscope, Interventional Pulmonology
- Medical subject headings
- Pulmonary Atelectasis, Hemoptysis, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Use BronchoscopeDevice
The interventional procedure is performed with a single use bronchoscope.
Standard BronchoscopeDevice
The interventional procedure is performed with a standard bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| Single Use Bronchoscope | Experimental | Not described Receives: Device: Single Use Bronchoscope |
| Standard Bronchoscope | Active comparator | Not described Receives: Device: Standard Bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall performance
Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)
Measured: through study completion, an average of 12 months
Secondary outcomes (5)
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)
Measured: through study completion, an average of 12 months
Suction
Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)
Measured: through study completion, an average of 12 months
Image quality
Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)
Measured: through study completion, an average of 12 months
Bleeding control
Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)
Measured: through study completion, an average of 12 months
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)
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start27 Nov 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Glodić, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144398
- Sponsor's protocol ID
- 8.1-22/21-2; 02/013AG
- Status last verified
- Aug 2024
- First submitted
- 13 Nov 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06144398
- Acronym / sponsor ID
- 8.1-22/21-2; 02/013AG
- Conditions
- Atelectasis, Hemoptysis, Stridor
- Keywords
- Bronchoscopy, Single Use Flexible Bronchoscope, Interventional Pulmonology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Use Bronchoscope | Experimental | Device: Single Use Bronchoscope |
| Standard Bronchoscope | Active comparator | Device: Standard Bronchoscope |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients requiring an interventional pulmonary procedure during the study period
- Signed informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Use BronchoscopeThe interventional procedure is performed with a single use bronchoscope. | Device | Single Use Bronchoscope |
| Standard BronchoscopeThe interventional procedure is performed with a standard bronchoscope. | Device | Standard Bronchoscope |
Primary outcome
Overall performance
Time frame: 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)
5 secondary outcomes
Functionality, handle and interface
Time frame: through study completion, an average of 12 months
Suction
Time frame: through study completion, an average of 12 months
Image quality
Time frame: through study completion, an average of 12 months
Bleeding control
Time frame: through study completion, an average of 12 months
Compatibility
Time frame: through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Use Bronchoscope and Standard Bronchoscope in people with Atelectasis and Hemoptysis, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall performance (time frame: through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.