MIPP-PNX1: Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Sponsor
BetaGlue Technologies spa (Industry)
Overall Status
Completed
CT.gov ID
NCT04071509
Collaborator
(none)
40
3
1
13.7
13.3
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.
Actual Study Start Date
:
Feb 4, 2019
Actual Primary Completion Date
:
Feb 27, 2020
Actual Study Completion Date
:
Mar 27, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Percutaneous Lung Biopsy
|
Device: Percutaneous 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.
|
Outcome Measures
Primary Outcome Measures
- Rate of complications associated with percutaneous lung biopsy [48 hours after procedure]
incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- BetaGlue Technologies spa
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
BetaGlue Technologies spa
ClinicalTrials.gov Identifier:
NCT04071509
Other Study ID Numbers:
- MIPP-PNX1
First Posted:
Aug 28, 2019
Last Update Posted:
Jul 14, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BetaGlue Technologies spa
Additional relevant MeSH terms: