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NoduleCRYOPROBENCT05230992

Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

A study testing Cryoprobes First and Cryoprobes Second in people with Nodule, run by Elsan at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nodule
What is being tested?
Cryoprobes First and Cryoprobes Second
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteFrance
Study dates
5 Nov 2022to 31 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with a tumor of any location with a draining bronchus (primary lung cancer or lung metastases)
  • Suspected lung nodule(s) with anatomical situation on mid 1/3 CT
  • Presence of at least one lung nodule of sufficient size on CT to allow for at least 8 tissue samples
  • Male or female aged ≥ 18 years
  • Mandatory membership in a health insurance plan
  • Patient who has been informed about the study and has signed the informed consent form

Who cannot join

  • Proximal or distal pulmonary nodule(s)
  • Pacemaker patient
  • Pregnant or nursing women
  • Patients under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pneumologie Elsan Santé Atlantique

    Saint-Herblain, 44800

Other trials in France

About this study

Official title: Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.

There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.

The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

Read the detailed description

Concerning the interventional pneumology technique, it is performed in two steps: identification of the mass with the mini ultrasound probe and then distal sampling with a small biopsy forceps. Experience shows that there is a significant difference between the identification of the mass, which is fairly conclusive, and the samples, which are much less productive (60% at best), because it is necessary that :

  • that the tumor is endo-bronchial,
  • that the forceps open sufficiently to take samples by back and forth movements
  • but, on the other hand, that the bronchus is not too wide.

The use of cryoprobes would allow to take more tissue by freezing. The target tissue freezes at the tip of the cryoprobe and can be detached by traction. The longer the freezing time, the more tissue is removed.

Various studies of endo-bronchial visible tumor diagnosis have compared these 2 sampling techniques (cryoprobe and conventional biopsy forceps). The cryoextraction technique performed by cryoprobes has a superior diagnostic yield (compared to flexible forceps biopsy) due to large biopsies and superior quality of the biopsied tissue (very few crush artifacts or hematomas; the morphological structure remains intact).

In this context, it seems interesting to compare these 2 techniques but in distal situation, under ultrasound detection with the mini-probes, for tumors not visible in endo-bronchial. The first samples taken in the investigating center by this technique are convincing.

In the framework of this study, in the same operating time and after ultrasound identification of the tumor, biopsies will be performed by conventional forceps (5 samples) and by cryoprobes (3 samples) on the same site. The sequence of use of one or the other technique will be randomly selected. Thus, each patient is his own control.

This first pilot study will explore the feasibility, effectiveness and safety of this procedure. Depending on the results of this comparative study, a second study including more patients will validate this procedure.

Conditions
Nodule
Being tested
Cryoprobes First, Cryoprobes Second

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryoprobes FirstDevice

    In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.

  • Cryoprobes SecondDevice

    In this second experimental group, the same medical devices are used but in the other order.

Study groups in NCT05230992
Study groupRoleWhat they receive
Cryoprobes FirstExperimentalUse of cryoprobes and then conventional forceps during the same operating time.
Receives: Device: Cryoprobes First
Cryoprobes SecondExperimentalUse of conventional forceps and then cryoprobes during the same operating time.
Receives: Device: Cryoprobes Second

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity of samples by cryoprobes

    Histological diagnosis from the material collected by cryoprobes and conventional forceps

    Measured: Within 24 hours after intervention

Secondary outcomes (2)

  1. Specificity, sensitivity, and predictive values of each technique

    specificity, sensitivity, predictive values

    Measured: Within 24 hours after intervention

  2. Tolerance and safety of the samples taken

    Collection of adverse events for the duration of the study.

    Measured: 15 Days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start5 Nov 2022
  3. Primary completion30 Nov 2023
  4. Study completion31 Dec 2023

Resources

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
Model description
This is a clinical investigation of a CE (Communauté Européenne)-marked medical device that is monocentric, interventional, prospective, comparative, randomized, open-label, with cross-over design.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230992
Sponsor's protocol ID
CRYOPROBE
Other IDs
2021-A01209-32
Acronym
CRYOPROBE
Status last verified
Feb 2024
First submitted
24 Sep 2021
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dhooria S, Sehgal IS, Aggarwal AN, Behera D, Agarwal R. Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta-Analysis. Respir Care. 2016 May;61(5):700-12. doi: 10.4187/respcare.04488. Epub 2016 Mar 1.

    PubMed 26932382

  • Hagmeyer L, Theegarten D, Treml M, Priegnitz C, Randerath W. Validation of transbronchial cryobiopsy in interstitial lung disease - interim analysis of a prospective trial and critical review of the literature. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):2-9.

    PubMed 27055830

  • Montufar F, Moral LD, Labarca G, Folch E, Majid A, Fernandez-Bussy S. [Transbronchial cryobiopsies and cryotherapy in lung diseases]. Rev Med Chil. 2018 Sep;146(9):1033-1040. doi: 10.4067/s0034-98872018000901033. Spanish.

    PubMed 30725025

  • Gershman E, Fruchter O, Benjamin F, Nader AR, Rosengarten D, Rusanov V, Fridel L, Kramer MR. Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases. Respiration. 2015;90(1):40-6. doi: 10.1159/000381921. Epub 2015 May 20.

    PubMed 25998966

  • Schumann C, Hetzel J, Babiak AJ, Merk T, Wibmer T, Moller P, Lepper PM, Hetzel M. Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. J Thorac Cardiovasc Surg. 2010 Aug;140(2):417-21. doi: 10.1016/j.jtcvs.2009.12.028. Epub 2010 Mar 11.

    PubMed 20226474

  • Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.

    PubMed 21852332

Questions about this trial

What is this clinical trial studying?

A study testing Cryoprobes First and Cryoprobes Second in people with Nodule, run by Elsan at 1 site in France.

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 6 inclusion and 4 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 14 Feb 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 France. 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?

Validity of samples by cryoprobes (time frame: Within 24 hours after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05230992, which also lists 6 linked publications.

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 14 Feb 2024.

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