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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 27, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Percutaneous Lung Biopsy

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BetaGlue Technologies spa
  • Provider of Information About this Clinical Study
    • Sponsor

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