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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471324
Other study ID # Cryo SPN 1.1 trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2020
Est. completion date August 31, 2020

Study information

Verified date October 2020
Source Thoraxklinik-Heidelberg gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray fluoroscopy, the diagnostic value of this method depends strongly on the size, location and relationship of the foci to the airways as well as their radiological representability. By inserting radial 20 MHz ultrasound probes through the working channel of a flexible bronchoscope into the periphery of the lung, the detection of peripheral foci can be improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope, even smaller round foci in the periphery of the lung can be detected. For some years now, tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in lesions that can only be reached endoscopically tangentially, advantages have been shown over forceps biopsy. Much larger tissue samples can be obtained without increasing the complication rate. Studies showed that the combination of the EBUS navigation technique with the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe with an ultra-thin bronchoscope together with the radial EBUS can further improve the diagnosis. This study is a non-randomized pilot study to prove the feasibility of this procedure. The EBUS probe and the bronchoscope are CE certified for this application. The study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University Hospital.

A total of 30 patients with an indication for transbronchial biopsy will be prospectively included. All patients will be examined according to the clinical standard. After a freezing time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken depending on the investigator's assessment. The samples will be collected separately and the order of the biopsies will be recorded. The primary endpoint is the feasibility of the procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and success rate depending on the position of the EBUS probe (tangential or central).


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Single or multiple peripheral pulmonary round foci in CT

- signed patient information

Exclusion Criteria:

- severe co-mornidity

- no signed patien information

- contraindication for intervention

Study Design


Related Conditions & MeSH terms


Intervention

Device:
EBUS cryo probe
patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope

Locations

Country Name City State
Germany Thoraxklinik Universitaetsmedizin Heidelberg Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor Collaborator
Thoraxklinik-Heidelberg gGmbH Erbe Elektromedizin GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion Pathological assessment of biopsies for ILD diagnosis Day 1
Secondary Bleeding time in seconds Assessed by using a stop watch and entering data into a questionnaire Day 1 until Day 2
Secondary Size of biopsies Planimetry Day 1
Secondary Quality of biopsies artefact-free biopsies Day 1
Secondary Exacerbation rate Assessment of exacerbations until 4 weeks after biopsy 4 weeks after biopsy
See also
  Status Clinical Trial Phase
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Recruiting NCT03927235 - The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases N/A
Not yet recruiting NCT06275295 - A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Not yet recruiting NCT06251687 - Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis N/A