Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device

Complications in Diagnostic Percutaneous Lung Biopsy Procedures Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071509
• Other study ID #: MIPP-PNX1
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: March 27, 2020

Study information

• Verified date: August 2019
• Source: BetaGlue Technologies spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications in Diagnostic Percutaneous Lung Biopsy Procedures
• Pneumothorax

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Tumori Bari Giovanni Paolo II	Bari
Italy	Fondazione Policlinico Universitario A. Gemelli	Roma
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
BetaGlue Technologies spa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complications associated with percutaneous lung biopsy	incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)	48 hours after procedure