Complications in Diagnostic Percutaneous Lung Biopsy ProceduresMIPP-PNX1NCT04071509
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
A study testing Percutaneous Lung Biopsy in people with Complications in Diagnostic Percutaneous Lung Biopsy Procedures, run by BetaGlue Technologies spa at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complications in Diagnostic Percutaneous Lung Biopsy Procedures
- What is being tested?
- Percutaneous Lung Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesItaly
- Study dates
- 4 Feb 2019to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication for diagnostic percutaneous lung biopsy
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Italy3 sites
Istituto Tumori Bari Giovanni Paolo II
Bari, 70124
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
About this study
Official title: 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.
- Being tested
- Percutaneous Lung Biopsy
- Keywords
- Lung Biopsy, pneumothorax, interventional radiology
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Lung BiopsyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Lung Biopsy | Experimental | Not described Receives: Device: Percutaneous Lung Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications associated with percutaneous lung biopsy
incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
Measured: 48 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Feb 2019
- Primary completion27 Feb 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications in Diagnostic Percutaneous Lung Biopsy ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BetaGlue Technologies spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071509
- Sponsor's protocol ID
- MIPP-PNX1
- Acronym
- MIPP-PNX1
- Status last verified
- Aug 2019
- First submitted
- 19 May 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gadaleta CD, Iezzi R, Tanzilli A, Puppini G, Carriero PL, Amato A. Pilot clinical study on the prevention of complications after lung biopsy by the MIPP kit PNX device. Transl Cancer Res. 2022 Dec;11(12):4338-4348. doi: 10.21037/tcr-22-1203.
PubMed 36644169
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.
- ClinicalTrials.gov ID
- NCT04071509
- Acronym / sponsor ID
- MIPP-PNX1 / MIPP-PNX1
- Keywords
- Lung Biopsy, pneumothorax, interventional radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BetaGlue Technologies spaIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Lung Biopsy | Experimental | Device: Percutaneous Lung Biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical indication for diagnostic percutaneous lung biopsy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Lung BiopsyPatients 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. | Device | Percutaneous Lung Biopsy |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 36644169Gadaleta CD, Iezzi R, Tanzilli A, Puppini G, Carriero PL, Amato A. Pilot clinical study on the prevention of complications after lung biopsy by the MIPP kit PNX device. Transl Cancer Res. 2022 Dec;11(12):4338-4348. doi: 10.21037/tcr-22-1203.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Lung Biopsy in people with Complications in Diagnostic Percutaneous Lung Biopsy Procedures, run by BetaGlue Technologies spa at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications associated with percutaneous lung biopsy (time frame: 48 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.