Lung DiseasesNCT02611297
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
A study testing Cryoprobe in people with Lung Diseases and Interstitial Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.
Trial summary
The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Diseases, Interstitial Disease
- What is being tested?
- Cryoprobe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2013to Dec 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Patients with mechanical ventilation.
- Patients with diffuse lung disease of unknown etiology.
- Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
- Inform consent signed by family.
Who cannot join
- Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio > 1.5).
- Comorbidities that could increase the risk of the TBLB.
- Bullous emphysema.
- Hemoptysis, pneumothorax.
- Severe respiratory insufficiency requiring PEEP >12 cm H2O
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Germans Tries i Pujol Hospital
Badalona, Barcelona, 08916
Felipe Andreo, MD, PhD, fandreo@separ.es
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Virginia Pajares, MD, PhD, +34935565792, vpajares@santpau.cat
Alfons Torrego, M.D.
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Carlos Agustí, MD, PhD, +3493 227 54 00, CAGUSTI@clinic.ub.es
About this study
The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.
- Conditions
- Lung Diseases, Interstitial Disease
- Being tested
- Cryoprobe
- Keywords
- Cryoprobes, Cryobiopsy, Transbronchial lung biopsy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoprobeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial lung biopsy with cryoprobe | Other | Not described Receives: Procedure: Cryoprobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
Measured: 27 months
Secondary outcomes (1)
Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Virginia Pajares, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611297
- Sponsor's protocol ID
- IIBSP-CRI-2013-142
- Status last verified
- Oct 2015
- First submitted
- 21 May 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02611297
- Acronym / sponsor ID
- IIBSP-CRI-2013-142
- Conditions
- Lung Diseases, Interstitial Disease
- Keywords
- Cryoprobes, Cryobiopsy, Transbronchial lung biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 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.
The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transbronchial lung biopsy with cryoprobe | Other | Procedure: Cryoprobe |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Patients with mechanical ventilation.
- Patients with diffuse lung disease of unknown etiology.
- Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
- Inform consent signed by family.
Key exclusion criteria (5 listed)
- Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio > 1.5).
- Comorbidities that could increase the risk of the TBLB.
- Bullous emphysema.
- Hemoptysis, pneumothorax.
- Severe respiratory insufficiency requiring PEEP >12 cm H2O
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 |
|---|---|---|
| Cryoprobe | Procedure or surgery | Transbronchial lung biopsy with cryoprobe |
Primary outcome
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
Time frame: 27 months
1 secondary outcome
Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes
Time frame: 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Virginia Pajares, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoprobe in people with Lung Diseases and Interstitial Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 Virginia Pajares, MD, PhD (+34935565972, vpajares@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe (time frame: 27 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 20 Nov 2015.