Interstitial Lung DiseaseNCT05311345
Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.
An observational study of Interstitial Lung Disease, run by Aarhus University Hospital.
Trial summary
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2015to 1 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under investigation for Interstitial lung diseases that were having cryobiopsies performed.
Who may be able to join
- >18years of age
- suspected of Interstitial lung Disease
- cryobiopsies performed.
Who cannot join
- FVC below 50% of predicted
- DLCO below 35%
- Body Mass Index (BMI) above 35
- pulmonary hypertension with a tricuspidal gradient above 40 mmHg
- other cardiac or other comorbidities that would increase the risk of complications
About this study
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.
- Conditions
- Interstitial Lung Disease
- Keywords
- Cryobiopsy
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax
Pneumothorax, hemorrhage, acute exacerbation and death
Measured: 2 weeks
Hemorrhage
Hemorrhage during the procedure
Measured: 3 days
Acute exacerbation
Acute exacerbation after the procedure
Measured: 100 days
Mortality
Mortality after the procedure
Measured: 100 days
Secondary outcomes (1)
Diagnostic yield
Diagnostic yield is discussed at multidisciplinary team meetings i.e, adequate biopsies (>50% alveolated biopsies), histologic pattern, kontribution to the diagnosis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 Nov 2015
- Primary completion10 Sep 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sissel Kronborg-White, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311345
- Sponsor's protocol ID
- Cryobiopsy 250
- Status last verified
- Mar 2022
- First submitted
- 17 Apr 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant data and study Protocol can be shared with other researcher upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.
- ClinicalTrials.gov ID
- NCT05311345
- Acronym / sponsor ID
- Cryobiopsy 250
- Conditions
- Interstitial Lung Disease
- Keywords
- Cryobiopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Apr 2022 (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.
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under investigation for Interstitial lung diseases that were having cryobiopsies performed.
Key inclusion criteria (3 listed)
- >18years of age
- suspected of Interstitial lung Disease
- cryobiopsies performed.
Key exclusion criteria (5 listed)
- FVC below 50% of predicted
- DLCO below 35%
- Body Mass Index (BMI) above 35
- pulmonary hypertension with a tricuspidal gradient above 40 mmHg
- other cardiac or other comorbidities that would increase the risk of complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pneumothorax
Time frame: 2 weeks
Pneumothorax, hemorrhage, acute exacerbation and death
Hemorrhage
Time frame: 3 days
Hemorrhage during the procedure
Acute exacerbation
Time frame: 100 days
Acute exacerbation after the procedure
Mortality
Time frame: 100 days
Mortality after the procedure
1 secondary outcome
Diagnostic yield
Time frame: 1 month
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 5 Apr 2022.
- Individual participant dataSharing planned: Undecided. Participant data and study Protocol can be shared with other researcher upon reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Aarhus University Hospital.
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 5 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Pneumothorax (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 5 Apr 2022.