Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device (MIPP-PNX1)

Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.

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.

Study Overview

• Status: Completed
• Conditions: Complications in Diagnostic Percutaneous Lung Biopsy Procedures
• Intervention / Treatment: Device: Percutaneous Lung Biopsy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Istituto Tumori Bari Giovanni Paolo II
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications associated with percutaneous lung biopsy	incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)	48 hours after procedure

Collaborators and Investigators

• Sponsor: BetaGlue Technologies spa

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Lung Biopsy, pneumothorax, interventional radiology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: MIPP-PNX1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No