Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy 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.

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Key information

Conditions

Complications in Diagnostic Percutaneous Lung Biopsy Procedures Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Tumori Bari Giovanni Paolo II, Bari, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Lung Biopsy

Device

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

BetaGlue Technologies spa

Industry

Registry information

Official study title

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

Acronym: MIPP-PNX1

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 28, 2019
Registry last updated: Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed