Back to resultsPrevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device (MIPP-PNX1)
Primary Purpose
Complications in Diagnostic Percutaneous Lung Biopsy Procedures
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Percutaneous Lung Biopsy
Sponsored by
About this trial
This is an interventional other trial for Complications in Diagnostic Percutaneous Lung Biopsy Procedures focused on measuring Lung Biopsy, pneumothorax, interventional radiology
Eligibility Criteria
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
Sites / Locations
- Istituto Tumori Bari Giovanni Paolo II
- Fondazione Policlinico Universitario A. Gemelli
- Azienda Ospedaliera Universitaria Integrata Verona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous Lung Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Rate of complications associated with percutaneous lung biopsy
incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04071509
Brief Title
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Acronym
MIPP-PNX1
Official Title
Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BetaGlue Technologies spa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications in Diagnostic Percutaneous Lung Biopsy Procedures
Keywords
Lung Biopsy, pneumothorax, interventional radiology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Lung Biopsy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Percutaneous Lung Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of complications associated with percutaneous lung biopsy
Description
incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
Time Frame
48 hours after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istituto Tumori Bari Giovanni Paolo II
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
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