Interstitial Lung DiseaseNCT02563730
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
A study testing Lung biopsy in people with Interstitial Lung Disease, run by University Hospital Tuebingen at 6 sites in 4 countries.
Trial summary
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Lung biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Nov 2014to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IIP suspected on clinical and radiologic grounds
Who cannot join
- Age >80y and <18y
- FVC< 55%, DCO<35%
- Platelet count <100000/µl
- acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
- INR > l,3,
- elevated PTT (> 40 s)
- documented pulmonary hypertension PAPS >50mmHg
- HR-CT highly suspicious for sarcoidosis
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites, 3 recruiting
- Recruiting
Ruhrlandklinik
Essen, 45239
Ulrich Costabel, 0201-433-4021
Kaid Darwiche
- Recruiting
Thoraxklinik
Heidelberg, 69126
Michael Kreuter, PD, 06221/396 0
- Recruiting
University Hospital Tuebingen
Tübingen
Juergen Hetzel, MD, 0049-7071-2982714, juergen.hetzel@med.uni-tuebingen.de
Michael Boeckeler, MD
Italy1 site, 1 recruiting
- Recruiting
Ospedale G.B. Morgagni
Forlì, 47100
Poletti, Prof., 0543 735452
Spain1 site, 1 recruiting
- Recruiting
Respiratory Department Hospital of Santa Creu i Sant Pau
Barcelona, 08025
Alfons Torrego, (+34) 93 556 59 72
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6LR
Athol Wells, +44 (0)20 7352 8121
About this study
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia
- Conditions
- Interstitial Lung Disease
- Being tested
- Lung biopsy
- Keywords
- Cryobiopsy, lung biopsy, interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung biopsyProcedure or surgery
transbronchial lung biopsy. First kryobiopsy, second open biopsy
| Study group | Role | What they receive |
|---|---|---|
| Lung biopsy | Experimental | assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS Receives: Procedure: Lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
Measured: two weeks
Secondary outcomes (10)
numer of bleeding events
Measured: 1 day
Rate of pneumothoraxes
Measured: 1 day
numer of exacerbations after biopsy
Measured: 6 weeks
Contribution of BAL and cryobiopsy to diagnosis
Measured: 2 weeks
Size of specimen
Measured: 2 weeks
Quality of specimen
Measured: 2 weeks
Distribution of histological changes in the specimen
Measured: 2 weeks
Influence of the size of the cryoprobe in the primary endpoint
Measured: 2 weeks
Comparative group (out of trial) - who are referred for VATS directly ['positive control group']
Measured: 6 weeks
Rate of exacerbations after cryobiopsy and after surgical biopsy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
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 University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boeckeler, Michael, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563730
- Sponsor's protocol ID
- CRYO-VATS
- Status last verified
- Oct 2016
- First submitted
- 2 May 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02563730
- Acronym / sponsor ID
- CRYO-VATS
- Conditions
- Interstitial Lung Disease
- Keywords
- Cryobiopsy, lung biopsy, interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- 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 multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung biopsy | Experimental | Procedure: Lung biopsyassess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IIP suspected on clinical and radiologic grounds
Key exclusion criteria (8 listed)
- Age >80y and <18y
- FVC< 55%, DCO<35%
- Platelet count <100000/µl
- acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
- INR > l,3,
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 |
|---|---|---|
| Lung biopsytransbronchial lung biopsy. First kryobiopsy, second open biopsy | Procedure or surgery | Lung biopsy |
Primary outcome
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
Time frame: two weeks
10 secondary outcomes
numer of bleeding events
Time frame: 1 day
Rate of pneumothoraxes
Time frame: 1 day
numer of exacerbations after biopsy
Time frame: 6 weeks
Contribution of BAL and cryobiopsy to diagnosis
Time frame: 2 weeks
Size of specimen
Time frame: 2 weeks
Quality of specimen
Time frame: 2 weeks
Distribution of histological changes in the specimen
Time frame: 2 weeks
Influence of the size of the cryoprobe in the primary endpoint
Time frame: 2 weeks
Comparative group (out of trial) - who are referred for VATS directly ['positive control group']
Time frame: 6 weeks
Rate of exacerbations after cryobiopsy and after surgical biopsy
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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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.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung biopsy in people with Interstitial Lung Disease, run by University Hospital Tuebingen at 6 sites in 4 countries.
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 1 inclusion and 8 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Spain, United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy (time frame: two weeks). 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 26 Oct 2016.