Pleural EffusionEarly Phase 1NCT01472172
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
A Early Phase 1 study testing Cryobiopsy (Autoclavable cryoprobe 20416-032) in people with Pleural Effusion and Pleural Diseases, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pleural Diseases
- What is being tested?
- Cryobiopsy (Autoclavable cryoprobe 20416-032)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSlovenia
- Study dates
- Feb 2010to Nov 2013
- Phase
- Early Phase 1
- 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
Who may be able to join
- 18 or more years old
- Unilateral pleural effusion of unknown origin
- Pleural irregularities suspicious for pleural malignancy
- Referral for thoracoscopy after less invasive means of diagnosis had failed
Who cannot join
- Uncontrolled bleeding tendency
- Unstable cardiovascular status
- Severe heart failure
- ECOG performance status 4
- Persistent hypoxemia after evacuation of pleural fluid
- Pleural symphisis, fibrothorax
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.
Read the detailed description
The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.
- Conditions
- Pleural Effusion, Pleural Diseases
- Being tested
- Cryobiopsy (Autoclavable cryoprobe 20416-032)
- Keywords
- Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy
- Medical subject headings
- Pleural Effusion, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryobiopsy (Autoclavable cryoprobe 20416-032)Device
Also called Autoclavable cryoprobe 20416-032 (ERBE, Germany)
The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy | Experimental | Biopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation. The biopsy sample will by extracted by gently pulling of the probe. Receives: Device: Cryobiopsy (Autoclavable cryoprobe 20416-032) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
To determine, wheather cryobiopsy specimen can be obtained in each patient
Measured: 12 months
Size of biopsy samples
Size of the biopsy specimens in mm2
Measured: 12 months
Quality of the sample
Interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)
Assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles
Measured: 12 months
Secondary outcomes (1)
Bleeding
Number of patients with a certain degree of bleeding from biopsy site, described as:
1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation.
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 posted16 Nov 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
- Investigators
- Ales Rozman, MD, Principal investigator, University Clinic Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472172
- Sponsor's protocol ID
- Endo-0002
- Status last verified
- Dec 2013
- First submitted
- 9 Nov 2011
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
- ClinicalTrials.gov ID
- NCT01472172
- Acronym / sponsor ID
- Endo-0002
- Conditions
- Pleural Effusion, Pleural Diseases
- Keywords
- Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Nov 2011 (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 determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.
Detailed description
The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy | Experimental | Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)Biopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation. The biopsy sample will by extracted by gently pulling of the probe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or more years old
- Unilateral pleural effusion of unknown origin
- Pleural irregularities suspicious for pleural malignancy
- Referral for thoracoscopy after less invasive means of diagnosis had failed
Key exclusion criteria (6 listed)
- Uncontrolled bleeding tendency
- Unstable cardiovascular status
- Severe heart failure
- ECOG performance status 4
- Persistent hypoxemia after evacuation of pleural fluid
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 |
|---|---|---|
| Cryobiopsy (Autoclavable cryoprobe 20416-032)Also: Autoclavable cryoprobe 20416-032 (ERBE, Germany)The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline. | Device | Cryobiopsy |
Primary outcome
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
Time frame: 12 months
To determine, wheather cryobiopsy specimen can be obtained in each patient
Size of biopsy samples
Time frame: 12 months
Size of the biopsy specimens in mm2
Quality of the sample
Time frame: 12 months
Interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible) Assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles
1 secondary outcome
Bleeding
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 Dec 2013.
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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.
Ales Rozman, MD principal investigator
University Clinic Golnik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cryobiopsy (Autoclavable cryoprobe 20416-032) in people with Pleural Effusion and Pleural Diseases, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
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 4 inclusion and 6 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 Dec 2013. 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 Slovenia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe (time frame: 12 months). The study lists 3 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 Dec 2013.