PneumothoraxBROM-INCT06340178
CT-guided Lung Biopsy Risk Optimization Method
A study testing Fluid application during ct-guided lung biopsy in people with Pneumothorax and Biopsy, Needle, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumothorax, Biopsy, Needle, Risk Factors
- What is being tested?
- Fluid application during ct-guided lung biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Sep 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent (knowledge of project languages), >18 years.
- Indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or Status after unsuccessful transbronchial biopsy
- Indication for biopsy given by referring specialist (in patients).
Who cannot join
- Preintervention bleeding into the pleural cavity
- More than 1 lesion should be biopsied at the same time
- Infiltration of the thoracic wall
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10
Bern, 3010
Johannes Heverhagen, Prof, +41316322648, johannes.heverhagen@insel.ch
About this study
Official title: CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.
Read the detailed description
Study participants with written consent and the percutaneous, CT-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. After randomization, the intervention is performed by Interventional Radiology, either with or without prior fluid administration into the pleural space. Three samples are taken using either an 18G or 20G coaxial needle, and any complications are treated according to the clinical standard. The lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal DICOM images of them retrieved from Inselspital's Picture Archiving and Communication System (PACS), laboratory results, and clinical information are retrieved from RIS (radiological information system) and iPDOS® and KISS by Epic® (electronic medical record) and the associated histopathological findings from the Institute of Pathology, University of Bern, will be analyzed.
- Conditions
- Pneumothorax, Biopsy, Needle, Risk Factors, Radiology, Interventional
- Being tested
- Fluid application during ct-guided lung biopsy
- Keywords
- Image-Guided Biopsy, Risk Factors, Tomography, Biopsy, Pneumothorax
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid application during ct-guided lung biopsyProcedure or surgery
Injection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site
| Study group | Role | What they receive |
|---|---|---|
| Fluid administration | Experimental | Fluid is given in pleural or subpleural space during CT-guided lung biopsy. Receives: Procedure: Fluid application during ct-guided lung biopsy |
| No fluid administration | No intervention | No additional fluid is given prior to the CT-guided lung biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pneumothorax
Reduction of pneumothorax occurrence in patients with biopsy in dependent lung areas and pleural fluid administration compared to patients with biopsy in dependent lung areas without fluid administration. Immediately after the lung biopsy, the final CT scan of the intervention is used to check whether a pneumothorax is present or not - i.e. whether there is new air in the pleural cavity.
Measured: Immediate after biopsy, expected to be on average 5 minutes
Secondary outcomes (3)
Number of patients with bleeding
Local bleeding in lung parenchyma
Measured: Immediate after biopsy, expected to be on average 5 minutes
Number of patients with chest tube placement
Chest tube placement if pneumothorax is more than 2 cm immediate after biopsy or progressive pneumothorax over time
Measured: Immediate after biopsy, expected to be on average 5 minutes
Number of patients with air embolism
Evidence of air embolism in the postprocedural CT image
Measured: Immediate after biopsy, expected to be on average 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start29 Sep 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Brönnimann, MD, Principal investigator, Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340178
- Sponsor's protocol ID
- 2024-00246
- Acronym
- BROM-I
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data repository
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Lung Biopsy Risk Optimization Method - Effect of Fluid Application in the Pleural Cavity and the Gravitational Effect of Pleural Pressure
- ClinicalTrials.gov ID
- NCT06340178
- Acronym / sponsor ID
- BROM-I / 2024-00246
- Conditions
- Pneumothorax, Biopsy, Needle, Risk Factors, Radiology, Interventional
- Keywords
- Image-Guided Biopsy, Risk Factors, Tomography, Biopsy, Pneumothorax
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Apr 2024 (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.
The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.
Detailed description
Study participants with written consent and the percutaneous, CT-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. After randomization, the intervention is performed by Interventional Radiology, either with or without prior fluid administration into the pleural space. Three samples are taken using either an 18G or 20G coaxial needle, and any complications are treated according to the clinical standard. The lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal DICOM images of them retrieved from Inselspital's Picture Archiving and Communication System (PACS), laboratory results, and clinical information are retrieved from RIS (radiological information system) and iPDOS® and KISS by Epic® (electronic medical record) and the associated histopathological findings from the Institute of Pathology, University of Bern, will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid administration | Experimental | Procedure: Fluid application during ct-guided lung biopsyFluid is given in pleural or subpleural space during CT-guided lung biopsy. |
| No fluid administration | No intervention | –No additional fluid is given prior to the CT-guided lung biopsy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide informed consent (knowledge of project languages), >18 years.
- Indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or Status after unsuccessful transbronchial biopsy
- Indication for biopsy given by referring specialist (in patients).
Key exclusion criteria (4 listed)
- Preintervention bleeding into the pleural cavity
- More than 1 lesion should be biopsied at the same time
- Infiltration of the thoracic wall
- Pregnancy
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 |
|---|---|---|
| Fluid application during ct-guided lung biopsyInjection of a small amount of fluid (max. 20 ml sodium chlorid) in the pleural cavity at the biopsy site | Procedure or surgery | Fluid administration |
Primary outcome
Number of patients with pneumothorax
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Reduction of pneumothorax occurrence in patients with biopsy in dependent lung areas and pleural fluid administration compared to patients with biopsy in dependent lung areas without fluid administration. Immediately after the lung biopsy, the final CT scan of the intervention is used to check whether a pneumothorax is present or not - i.e. whether there is new air in the pleural cavity.
3 secondary outcomes
Number of patients with bleeding
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Number of patients with chest tube placement
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Number of patients with air embolism
Time frame: Immediate after biopsy, expected to be on average 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes. Data repository
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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.
Michael Brönnimann, MD principal investigator
Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, 3010 Bern, Switzerland;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid application during ct-guided lung biopsy in people with Pneumothorax and Biopsy, Needle, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Brönnimann, MD (+41316326510, michael.broennimann@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with pneumothorax (time frame: Immediate after biopsy, expected to be on average 5 minutes). 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 2 Feb 2026.