Computed Tomography, Biopsy, Pneumothorax, Chest Tube, PlugNCT03526640
Computed Tomography (CT) Guided Lung Biopsy With Plug
A study testing The BioSentry Tract Sealant System in people with Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
Protocol Title: Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
- What is being tested?
- The BioSentry Tract Sealant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteNorway
- Study dates
- 4 May 2018to 4 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study related procedure
- Male or female, aged ≥18 years or older
- Percutaneous transthoracic needle lung biopsy indicated
Who cannot join
- There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haseem Ashraf
Lørenskog, Select A State, 1476
Haseem Ashraf, Associate professor, PhD, 0047 6796572, ashr@ahus.no
About this study
Official title: Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
Protocol Title:
Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
Read the detailed description
Protocol Summary:
Prospective, randomized, controlled, unblinded, post-market, single-center clinical study
Objectives:
Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).
Primary Objective:
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Secondary Objectives:
Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions
- Being tested
- The BioSentry Tract Sealant System
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BioSentry Tract Sealant SystemDevice
The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue.
| Study group | Role | What they receive |
|---|---|---|
| Plug Arm | Experimental | Participants randomized for plug arm will be treated with a plug after CT guided is conducted. Receives: Device: The BioSentry Tract Sealant System |
| Non Plug arm | No intervention | No Intervention, i.a. CT guided biopsy without plug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of chest tube
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start4 May 2018
- Primary completion4 Aug 2020 (estimated)
- Study completion4 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Computed Tomography, Biopsy, Pneumothorax, Chest Tube, PlugStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomized design
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haseem Ashraf, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526640
- Sponsor's protocol ID
- AHUS plug study 001
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zaetta JM, Licht MO, Fisher JS, Avelar RL; Bio-Seal Study Group. A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021.
PubMed 20656223Ahrar JU, Gupta S, Ensor JE, Mahvash A, Sabir SH, Steele JR, McRae SE, Avritscher R, Huang SY, Odisio BC, Murthy R, Ahrar K, Wallace MJ, Tam AL. Efficacy of a Self-expanding Tract Sealant Device in the Reduction of Pneumothorax and Chest Tube Placement Rates After Percutaneous Lung Biopsy: A Matched Controlled Study Using Propensity Score Analysis. Cardiovasc Intervent Radiol. 2017 Feb;40(2):270-276. doi: 10.1007/s00270-016-1489-9. Epub 2016 Nov 8.
PubMed 27826786Grage RA, Naveed MA, Keogh S, Wang D. Efficacy of a Dehydrated Hydrogel Plug to Reduce Complications Associated With Computed Tomography-guided Percutaneous Transthoracic Needle Biopsy. J Thorac Imaging. 2017 Jan;32(1):57-62. doi: 10.1097/RTI.0000000000000247.
PubMed 27870824
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03526640
- Acronym / sponsor ID
- AHUS plug study 001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 4 Aug 2020 (estimated)
- Study completion
- 4 Aug 2023 (estimated)
- First posted
- 16 May 2018 (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.
Protocol Title:
Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
Detailed description
Protocol Summary:
Prospective, randomized, controlled, unblinded, post-market, single-center clinical study
Objectives:
Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).
Primary Objective:
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Secondary Objectives:
Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomized design
| Arm | Type | Receives |
|---|---|---|
| Plug Arm | Experimental | Device: The BioSentry Tract Sealant SystemParticipants randomized for plug arm will be treated with a plug after CT guided is conducted. |
| Non Plug arm | No intervention | –No Intervention, i.a. CT guided biopsy without plug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent prior to any study related procedure
- Male or female, aged ≥18 years or older
- Percutaneous transthoracic needle lung biopsy indicated
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the 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 |
|---|---|---|
| The BioSentry Tract Sealant SystemThe BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue. | Device | Plug Arm |
Primary outcome
Evaluate the rate of chest tube
Time frame: 2 years
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Background: PubMed 20656223Zaetta JM, Licht MO, Fisher JS, Avelar RL; Bio-Seal Study Group. A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021.
- Background: PubMed 27826786Ahrar JU, Gupta S, Ensor JE, Mahvash A, Sabir SH, Steele JR, McRae SE, Avritscher R, Huang SY, Odisio BC, Murthy R, Ahrar K, Wallace MJ, Tam AL. Efficacy of a Self-expanding Tract Sealant Device in the Reduction of Pneumothorax and Chest Tube Placement Rates After Percutaneous Lung Biopsy: A Matched Controlled Study Using Propensity Score Analysis. Cardiovasc Intervent Radiol. 2017 Feb;40(2):270-276. doi: 10.1007/s00270-016-1489-9. Epub 2016 Nov 8.
- Background: PubMed 27870824Grage RA, Naveed MA, Keogh S, Wang D. Efficacy of a Dehydrated Hydrogel Plug to Reduce Complications Associated With Computed Tomography-guided Percutaneous Transthoracic Needle Biopsy. J Thorac Imaging. 2017 Jan;32(1):57-62. doi: 10.1097/RTI.0000000000000247.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BioSentry Tract Sealant System in people with Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug, run by University Hospital, Akershus at 1 site in Norway.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haseem Ashraf, Associate professor, PhD (0047 67964572, ashr@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rate of chest tube (time frame: 2 years). 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 NCT03526640, which also lists 3 linked publications.
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 16 May 2018.