Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Not Applicable
Completed
- Conditions
- Complications in Diagnostic Percutaneous Lung Biopsy Procedures
- Interventions
- Device: Percutaneous Lung Biopsy
- Registration Number
- NCT04071509
- Lead Sponsor
- BetaGlue Technologies spa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Percutaneous Lung Biopsy Percutaneous Lung Biopsy -
- Primary Outcome Measures
Name Time Method Rate of complications associated with percutaneous lung biopsy 48 hours after procedure incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Fondazione Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Istituto Tumori Bari Giovanni Paolo II
🇮🇹Bari, Italy