Bronchi--DiseasesNCT05399082
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
A study testing Cryoprobe biopsy and Forceps biopsy in people with Bronchi--Diseases and Lung Diseases, Obstructive, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass
- What is being tested?
- Cryoprobe biopsy and Forceps biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 11 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.
- Lesion Criteria:
- Pulmonary nodules of 8-50mm in largest dimension.
Who cannot join
- Patients with known bleeding diathesis; Platelet count < 50,000.
- Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
- Inability or unwillingness to give informed consent.
- Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
- Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
- Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
- International Normalized Ratio (INR) < 1.5.
- Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.
- Conditions
- Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass
- Being tested
- Cryoprobe biopsy, Forceps biopsy
- Medical subject headings
- Bronchial Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoprobe biopsyDevice
A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue
Forceps biopsyProcedure or surgery
Biopsy forceps used to collect tissue
| Study group | Role | What they receive |
|---|---|---|
| Standard forceps biopsy then research cryoprobe biopsy | Experimental | Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using forceps first followed by cryoprobe. Receives: Device: Cryoprobe biopsy; Procedure: Forceps biopsy |
| Research cryoprobe biopsy then standard forceps biopsy | Experimental | Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using the cryoprobe first followed by forceps. Receives: Device: Cryoprobe biopsy; Procedure: Forceps biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Successfully Obtain Sample
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
Measured: Baseline
Secondary outcomes (9)
Duration of Biopsy Procedure
Total time of biopsy procedure from first insertion of probe into robotic sheath to removal of specimens.
Measured: Biopsy procedure, approximately 3 hours
Freezing Time for Cryoprobe Biopsies
Total freezing time for cryoprobe biopsies, measured in seconds
Measured: Biopsy procedure, approximately 60 seconds
Number of Successful Biopsy Attempts
One attempt is defined as insertion of the biopsy probe into the robotic sheath, activation/employment of the biopsy mechanism at the target site and retrieval via the robotic sheath. A biopsy attempt is successful if a tissue sample that is considered by the bronchoscopist to be adequate for further pathological analysis can be retrieved.
Measured: Biopsy procedure, approximately 3 hours
Histological Accessibility Grade
Pathologic description ranging from insufficient to diagnostic material
Measured: Pathology review, approximately 1 day
Histological Diagnostic Yield
Defined as the ability of the pathologist to make a diagnostic statement based on the histological analysis of the obtained tissue samples. Graded 1-4 with 1 being insufficient tissue and 4 being diagnostic material.
Measured: Pathology review, approximately 1 day
Total Histological Area
The total histological area of the biopsy samples. Measured in (mm^2)
Measured: Pathology review, approximately 1 day
Crush Artifacts
The total percent area of crush artifacts identified in the biopsy samples (percent total area)
Measured: Pathology review, approximately 1 day
Other Pathologic Artifacts
The total percent area of other pathologic artifacts identified in the tissue biopsy samples that obscure pathological assessment (percent total area)
Measured: Pathology review, approximately 1 day
Different Tissue Types in the Tissue Specimen
The total percent area of different tissue types identified in the tissue biopsy samples. Defined as the total of alveoli, bronchus, mucus, blood, and target tissue (percent total area)
Measured: Pathology review, approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 Aug 2022
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchi--DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Principal investigator, Ryan M. Kern, Mayo Clinic
- Investigators
- Ryan Kern, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399082
- Sponsor's protocol ID
- 21-008716
- Status last verified
- Oct 2024
- First submitted
- 20 May 2022
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT05399082
- Acronym / sponsor ID
- 21-008716
- Conditions
- Bronchi--Diseases, Lung Diseases, Obstructive, Lesions Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard forceps biopsy then research cryoprobe biopsy | Experimental | Device: Cryoprobe biopsy, Procedure: Forceps biopsySubjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using forceps first followed by cryoprobe. |
| Research cryoprobe biopsy then standard forceps biopsy | Experimental | Device: Cryoprobe biopsy, Procedure: Forceps biopsySubjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using the cryoprobe first followed by forceps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.
- Pulmonary nodules of 8-50mm in largest dimension.
Key exclusion criteria (8 listed)
- Patients with known bleeding diathesis; Platelet count < 50,000.
- Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
- Inability or unwillingness to give informed consent.
- Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
- Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
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 biopsyA 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue | Device | Research cryoprobe biopsy then standard forceps biopsy, Standard forceps biopsy then research cryoprobe biopsy |
| Forceps biopsyBiopsy forceps used to collect tissue | Procedure or surgery | Research cryoprobe biopsy then standard forceps biopsy, Standard forceps biopsy then research cryoprobe biopsy |
Primary outcome
Ability to Successfully Obtain Sample
Time frame: Baseline
Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis
9 secondary outcomes
Duration of Biopsy Procedure
Time frame: Biopsy procedure, approximately 3 hours
Freezing Time for Cryoprobe Biopsies
Time frame: Biopsy procedure, approximately 60 seconds
Number of Successful Biopsy Attempts
Time frame: Biopsy procedure, approximately 3 hours
Histological Accessibility Grade
Time frame: Pathology review, approximately 1 day
Histological Diagnostic Yield
Time frame: Pathology review, approximately 1 day
Total Histological Area
Time frame: Pathology review, approximately 1 day
Crush Artifacts
Time frame: Pathology review, approximately 1 day
Other Pathologic Artifacts
Time frame: Pathology review, approximately 1 day
Different Tissue Types in the Tissue Specimen
Time frame: Pathology review, approximately 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ryan Kern, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoprobe biopsy and Forceps biopsy in people with Bronchi--Diseases and Lung Diseases, Obstructive, run by Mayo Clinic at 1 site in United States.
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 17 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ability to Successfully Obtain Sample (time frame: Baseline). 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 17 Oct 2024.