Complications in Diagnostic Percutaneous Lung Biopsy Procedures
Conditions
Keywords
Lung Biopsy, pneumothorax, interventional radiology
Brief summary
The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.
Interventions
DEVICEPercutaneous 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.
Sponsors
BetaGlue Technologies spa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical indication for diagnostic percutaneous lung biopsy
Exclusion criteria
* Pregnant, or breastfeeding patient (Female) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complications associated with percutaneous lung biopsy | 48 hours after procedure | incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage) |
Countries
Italy
Outcome results
None listed