Lung Transplant RejectionNCT06824402
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients
A study testing Forceps Biopsy and Cryoprobe Biopsy in people with Lung Transplant Rejection, run by Mayo Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are: Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Forceps Biopsy and Cryoprobe Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female lung transplant recipients age \>18 at the time of informed consent
- Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
- Be willing and able to sign the informed consent.
Who cannot join
- Patients with known bleeding diathesis
- Platelet count \<50,000 per μL within 14 days of the biopsy procedure
- 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 or study procedures
- Pregnant or nursing females, or females who intend to become pregnant
- Females of child-bearing potential who decline a pregnancy test prior to enrollment
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- If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
- International Normalized Ratio (INR) \>1.5
- Do Not Resuscitate (DNR) status
- Do Not Intubate (DNI) status
- Single lung transplant recipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
John Joerns
About this study
Official title: A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:
Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?
Read more
How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?
Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?
Which collection method has the least amount of procedural time?
Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.
Participants will:
Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.
Assessed for any adverse events following the biopsy for up to 30 days after transplant.
Read the detailed description
The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.
- Conditions
- Lung Transplant Rejection
- Being tested
- Forceps Biopsy, Cryoprobe Biopsy
- Keywords
- Lung Transplant, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forceps BiopsyDevice
10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA
Cryoprobe BiopsyDevice
3 transbronchial lung biopsies of two separate lobes will be obtained using a flexible cryoprobe: single-use, ø 1.1 mm (Erbe Elektromedizin GmbH, 20402-401) used with ERBECRYO 2 (Erbe Elektromedizin GmbH, 10402-000
| Study group | Role | What they receive |
|---|---|---|
| Cryoprobe Biopsy Method | Experimental | Cryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue. Receives: Device: Cryoprobe Biopsy |
| Forceps Biopsy Method | Active comparator | Olympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact. Receives: Device: Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and diagnostic yield of tissue samples
Histological accessibility grade is determined by the pathologist according to the Lung Allograft Standard Histological Analysis (LASHA) scale and the 2007 Revision of the 1996 working formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, published by the ISHLT.
Measured: Baseline
Secondary outcomes (2)
Time duration
Duration of each individual biopsy procedure from insertion of the bronchoscope after airway has been secured until bronchoscope is withdrawn. .
Measured: Baseline
Tissue sample adequacy
Number of biopsy samples that are adequate to determine rejection based on the presence of well expanded alveoli, as determined by the pathologist.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start17 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John O. Joerns, Mayo Clinic
- Investigators
- John Joerns, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824402
- Sponsor's protocol ID
- 23-011339
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT06824402
- Acronym / sponsor ID
- 23-011339
- Conditions
- Lung Transplant Rejection
- Keywords
- Lung Transplant, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:
Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?
How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?
Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?
Which collection method has the least amount of procedural time?
Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.
Participants will:
Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.
Assessed for any adverse events following the biopsy for up to 30 days after transplant.
Detailed description
The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoprobe Biopsy Method | Experimental | Device: Cryoprobe BiopsyCryoprobes which are flexible catheters that can be passed through the channel of a bronchoscope. Rapid cooling of tissue results from the Joule-Thomson effect which causes tissue to freeze and adhere to the probe. The biopsy is obtained by subsequently avulsing small fragments of tissue. |
| Forceps Biopsy Method | Active comparator | Device: Forceps BiopsyOlympus disposable EndoJaw is used to obtain samples as per the standard of clinical care usually resulting in crush artifact. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female lung transplant recipients age \>18 at the time of informed consent
- Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
- Be willing and able to sign the informed consent.
Key exclusion criteria (11 listed)
- Patients with known bleeding diathesis
- Platelet count \<50,000 per μL within 14 days of the biopsy procedure
- 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 or study procedures
- Pregnant or nursing females, or females who intend to become pregnant
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 Biopsy10-12 transbronchial lung biopsies will be obtained using standard of care biopsy forceps: Olympus disposable EndoJaw (FB-211), Olympus, USA | Device | Forceps Biopsy Method |
| Cryoprobe Biopsy3 transbronchial lung biopsies of two separate lobes will be obtained using a flexible cryoprobe: single-use, ø 1.1 mm (Erbe Elektromedizin GmbH, 20402-401) used with ERBECRYO 2 (Erbe Elektromedizin GmbH, 10402-000 | Device | Cryoprobe Biopsy Method |
Primary outcome
Quality and diagnostic yield of tissue samples
Time frame: Baseline
Histological accessibility grade is determined by the pathologist according to the Lung Allograft Standard Histological Analysis (LASHA) scale and the 2007 Revision of the 1996 working formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, published by the ISHLT.
2 secondary outcomes
Time duration
Time frame: Baseline
Tissue sample adequacy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
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.
John Joerns 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 Forceps Biopsy and Cryoprobe Biopsy in people with Lung Transplant Rejection, 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 11 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Joerns, MD (507-284-6616, joerns.john@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality and diagnostic yield of tissue samples (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 1 May 2026.