Lung; NodeCryo-NoduleNCT04885595
Diagnosis of Peripheral Lung Nodules Using Cryobiopsy
A study testing Forceps biopsy and cryobiopsy in people with Lung; Node, run by University of Zurich at 1 site in Switzerland.
Trial summary
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung; Node
- What is being tested?
- Forceps biopsy and cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2021to 30 May 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
- Age between 18 and 90 years
- Written informed consent after participant's information
Who cannot join
- Age < 18 and > 90 years
- Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- INR > 2 or Thrombocytes < 50000
- Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
- Anticoagulation with NOAK within 48 hours before biopsy
- Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
- Tumors suspicious of endobronchial growth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe
Read the detailed description
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.
- Conditions
- Lung; Node
- Being tested
- Forceps biopsy and cryobiopsy
- Keywords
- Cryobiopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forceps biopsy and cryobiopsyProcedure or surgery
Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.
| Study group | Role | What they receive |
|---|---|---|
| Forceps-Cryo 1.1 mm | Active comparator | Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session Receives: Procedure: Forceps biopsy and cryobiopsy |
| Forceps-Cryo 1.7 mm | Active comparator | Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session Receives: Procedure: Forceps biopsy and cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage
Measured: up to 1 month
Secondary outcomes (6)
Size of harvested tissue in millimeter
The biopsies are assessed for total size in millimeter
Measured: up to 1 month
Size of malign tissue in millimeter
The biopsies are assessed for size of malign tissue in milimeter
Measured: up to 1 month
Occurrence of bleeding events
Occurrence of bleeding events
Measured: up to 1 month
Size of artifact-free alvoelar space in percentage
Size of artifact-free alvoelar space in percentage
Measured: up to 1 month
Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)
Lesion orientation with regards of the radial endobronchial ultrasound probe
Measured: 1 day
Occurence of pneumothorax
Detection with X-ray
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Apr 2021
- Primary completion15 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; NodeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Steinack, University of Zurich
- Investigators
- Carolin Steinack, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885595
- Sponsor's protocol ID
- 2021-00323
- Acronym
- Cryo-Nodule
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04885595
- Acronym / sponsor ID
- Cryo-Nodule / 2021-00323
- Conditions
- Lung; Node
- Keywords
- Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 13 May 2021 (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.
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe
Detailed description
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forceps-Cryo 1.1 mm | Active comparator | Procedure: Forceps biopsy and cryobiopsyForceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session |
| Forceps-Cryo 1.7 mm | Active comparator | Procedure: Forceps biopsy and cryobiopsyForceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
- Age between 18 and 90 years
- Written informed consent after participant's information
Key exclusion criteria (8 listed)
- Age < 18 and > 90 years
- Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- INR > 2 or Thrombocytes < 50000
- Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
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 |
|---|---|---|
| Forceps biopsy and cryobiopsyOnce the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session. | Procedure or surgery | Forceps-Cryo 1.1 mm, Forceps-Cryo 1.7 mm |
Primary outcome
Diagnostic yield
Time frame: up to 1 month
The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage
6 secondary outcomes
Size of harvested tissue in millimeter
Time frame: up to 1 month
Size of malign tissue in millimeter
Time frame: up to 1 month
Occurrence of bleeding events
Time frame: up to 1 month
Size of artifact-free alvoelar space in percentage
Time frame: up to 1 month
Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)
Time frame: 1 day
Occurence of pneumothorax
Time frame: up to 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 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Lung; Node
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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.
Carolin Steinack, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forceps biopsy and cryobiopsy in people with Lung; Node, run by University of Zurich at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 28 Jun 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 Switzerland. 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?
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?
Diagnostic yield (time frame: up to 1 month). 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 28 Jun 2024.