Lung BiopsyPhase 3NCT02224924
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
A Phase 3 study testing ABPI and BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug in people with Lung Biopsy, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Biopsy
- What is being tested?
- ABPI and BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2014to 11 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
- Skin thickness ≤7 cm (from skin to pleura)
- Needle path without transgression of pleural fissure bleb, or bulla is possible
- Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
- Needle length ≤15
Who cannot join
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement
- Surgery
- Pleurodesis
- Radiation treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.
Read the detailed description
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.
- Conditions
- Lung Biopsy
- Being tested
- ABPI, BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
- Keywords
- Experimental: autologous blood patch injection (ABPI), Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug, 14-141
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPIOther
If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
BioSentry (formerly known as Bio-Seal) hydrogel Tract PlugDevice
If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
| Study group | Role | What they receive |
|---|---|---|
| autologous blood patch injection (ABPI) | Active comparator | Not described Receives: Other: ABPI |
| BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug | Experimental | Not described Receives: Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Rate of Pneumothorax
within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
Measured: 2 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study start21 Aug 2014
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung BiopsyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amgad Moussa, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224924
- Sponsor's protocol ID
- 14-141
- Status last verified
- Jan 2023
- First submitted
- 22 Aug 2014
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.
PubMed 30480487
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
- ClinicalTrials.gov ID
- NCT02224924
- Acronym / sponsor ID
- 14-141
- Conditions
- Lung Biopsy
- Keywords
- Experimental: autologous blood patch injection (ABPI), Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug, 14-141
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 21 Aug 2014 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.
Detailed description
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous blood patch injection (ABPI) | Active comparator | Other: ABPI |
| BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug | Experimental | Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
- Skin thickness ≤7 cm (from skin to pleura)
Key exclusion criteria (7 listed)
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement
- Surgery
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 |
|---|---|---|
| ABPIIf the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues. | Other | autologous blood patch injection (ABPI) |
| BioSentry (formerly known as Bio-Seal) hydrogel Tract PlugIf the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed. | Device | BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug |
Primary outcome
the Rate of Pneumothorax
Time frame: 2 hours post procedure
within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30480487Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Lung Biopsy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
Active, not recruitingObservational study
Analysis of Specimens From Individuals With Pulmonary Fibrosis
Pulmonary Fibrosis, Healthy Volunteers
Active, not recruitingPhase 2
Osimertinib In EGFR Mutant Lung Cancer
Carcinoma, Non-Small-Cell Lung
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.
Amgad Moussa, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABPI and BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug in people with Lung Biopsy, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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 8 inclusion and 7 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Rate of Pneumothorax (time frame: 2 hours post 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 NCT02224924, 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 30 Jan 2024.