Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
NCT ID: NCT04071509
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-02-04
2020-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Percutaneous Lung Biopsy
Percutaneous Lung Biopsy
Patients will undergo the usual biopsy procedure with a fine needle inserted through a larger guide needle, under CT guidance; at the end of the biopsy, the MIPP-Kit will be introduced through the same guide needle. The guide needle and the MIPP Kit will be retracted together slowly, whilst injecting BioGlue in appropriate amounts along the whole track, from the lesion to the skin.
Interventions
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Percutaneous Lung Biopsy
Patients will undergo the usual biopsy procedure with a fine needle inserted through a larger guide needle, under CT guidance; at the end of the biopsy, the MIPP-Kit will be introduced through the same guide needle. The guide needle and the MIPP Kit will be retracted together slowly, whilst injecting BioGlue in appropriate amounts along the whole track, from the lesion to the skin.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* actively participating in other clinical trials in the previous 30 days
* known allergies to the investigational device components
* comorbidities that preclude undergoing percutaneous lung biopsy procedure
* concomitant treatments that preclude undergoing percutaneous lung biopsy procedure
18 Years
80 Years
ALL
No
Sponsors
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BetaGlue Technologies spa
INDUSTRY
Responsible Party
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Locations
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Istituto Tumori Bari Giovanni Paolo II
Bari, , Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Countries
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References
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Gadaleta CD, Iezzi R, Tanzilli A, Puppini G, Carriero PL, Amato A. Pilot clinical study on the prevention of complications after lung biopsy by the MIPP kit PNX device. Transl Cancer Res. 2022 Dec;11(12):4338-4348. doi: 10.21037/tcr-22-1203.
Other Identifiers
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MIPP-PNX1
Identifier Type: -
Identifier Source: org_study_id
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