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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Lung Biopsy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Lung Biopsy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complications associated with percutaneous lung biopsy | incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage) | 48 hours after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Tumori Bari Giovanni Paolo II | Bari | 70124 | Italy | |||
| Fondazione Policlinico Universitario A. Gemelli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36644169 | Derived | 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. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| Roma |
| 00168 |
| Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |