Status:
COMPLETED
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Lead Sponsor:
BetaGlue Technologies spa
Conditions:
Complications in Diagnostic Percutaneous Lung Biopsy Procedures
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Clinical indication for diagnostic percutaneous lung biopsy
Exclusion
- 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
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04071509
Start Date
February 4 2019
End Date
March 27 2020
Last Update
July 14 2020
Active Locations (3)
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1
Istituto Tumori Bari Giovanni Paolo II
Bari, Italy, 70124
2
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168
3
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126