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

BetaGlue Technologies

Status: Completed

Conditions: Complications in Diagnostic Percutaneous Lung Biopsy Procedures

Treatments: Device: Percutaneous Lung Biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04071509

MIPP-PNX1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Percutaneous Lung Biopsy

Experimental group

Treatment:

Device: Percutaneous Lung Biopsy