Pulmonary DiseaseNCT06056882
Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
An observational study of Pulmonary Disease, run by University of Vienna at 1 site in Austria.
Trial summary
It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus. It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- CLE-guided cryobiopsy
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 20 Sep 2023to 30 Jun 2024
- Phase
- Observational
- 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
Study population: Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions
Who may be able to join
- >18 years
- Suspicion of lung carcinoma
Who cannot join
- Known allergy to fluorescin
- Pregnancy and/or lactation
- No discontinuation of ß-blocker 12 hours before intervention possible
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Daniela Gompelmann, 0043 1 40400 47730, daniela.gompelmann@meduniwien.ac.at
About this study
It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus.
It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation.
- Conditions
- Pulmonary Disease
- Being tested
- CLE-guided cryobiopsy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLE-guided cryobiopsyOther
During bronchoscopy, that is performed for suspicious pulmonary lesions, it is planned to use the CLE probe and cryoprobe simultaneously wafter detection of the round focus.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Other: CLE-guided cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility
Advers events
Measured: during bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Gompelmann, University of Vienna
- Investigators
- Daniela Gompelmann, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056882
- Sponsor's protocol ID
- 1.1
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT06056882
- Acronym / sponsor ID
- 1.1
- Conditions
- Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Sep 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.
It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus.
It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: CLE-guided cryobiopsy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for bronchoscopy and biopsy for suspicious pulmonary lesions
Key inclusion criteria (2 listed)
- >18 years
- Suspicion of lung carcinoma
Key exclusion criteria (3 listed)
- Known allergy to fluorescin
- Pregnancy and/or lactation
- No discontinuation of ß-blocker 12 hours before intervention possible
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 |
|---|---|---|
| CLE-guided cryobiopsyDuring bronchoscopy, that is performed for suspicious pulmonary lesions, it is planned to use the CLE probe and cryoprobe simultaneously wafter detection of the round focus. | Other | Study group |
Primary outcome
Safety and feasibility
Time frame: during bronchoscopy procedure
Advers events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Daniela Gompelmann principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by University of Vienna at 1 site in Austria.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Gompelmann (014040047730, daniela.gompelmann@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility (time frame: during bronchoscopy procedure). 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 12 Feb 2024.