Air Leak From LungNCT04317924
Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection
A study testing Polyglycolic acid felt in people with Air Leak From Lung, run by Boston Medical Center at 1 site in United States.
Trial summary
Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung
- What is being tested?
- Polyglycolic acid felt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective lung resection at BMC
- Intra-operative diagnosis of air leak
Who cannot join
- Patients undergoing emergency lung resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection
Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.
NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.
This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.
- Conditions
- Air Leak From Lung
- Being tested
- Polyglycolic acid felt, Standard of care
- Keywords
- Pneumostasis, Bio-absorbable mesh, Lung resection, Neoveil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglycolic acid feltDevice
Also called Neoveil
Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
Standard of careOther
Standard of care after air leak post lung resection
| Study group | Role | What they receive |
|---|---|---|
| Reinforcement of air leak | Experimental | Participants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin. Receives: Device: Polyglycolic acid felt |
| No reinforcement of air leak | Active comparator | Participants in this arm will receive standard of care for air leak post lung resection. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to removal of chest tubes
The time in hours to removal of chest tubes post lung resection will be abstracted from the electronic medical record of each participant.
Measured: 2 years
Secondary outcomes (2)
Length of hospital stay
The length of hospital stay in days will be abstracted from the electronic medical record of each participant.
Measured: 2 years
Number of participants with additional interventions for air leak
The number of participants requiring additional interventions post lung resection will be abstracted from the electronic medical record of each participant.
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 posted23 Mar 2020
- Study startOct 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Resources not available to conduct the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies of the same condition, open and under way.
- More trials run by Boston Medical 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified block randomization will be done using known predictors of prolonged air leak: 1) surgical procedure (wedge vs lobectomy) and 2) presence of pulmonary comorbidities (chronic obstructive pulmonary disease and emphysema).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gunze Limited
- Responsible party
- Sponsor
- Investigators
- Kei Suzuki, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317924
- Sponsor's protocol ID
- H-37652
- Status last verified
- Aug 2020
- First submitted
- 20 Mar 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection
- ClinicalTrials.gov ID
- NCT04317924
- Acronym / sponsor ID
- H-37652
- Conditions
- Air Leak From Lung
- Keywords
- Pneumostasis, Bio-absorbable mesh, Lung resection, Neoveil
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resources not available to conduct the research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Gunze Limited
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Mar 2020 (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.
Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.
NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.
This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratified block randomization will be done using known predictors of prolonged air leak: 1) surgical procedure (wedge vs lobectomy) and 2) presence of pulmonary comorbidities (chronic obstructive pulmonary disease and emphysema).
| Arm | Type | Receives |
|---|---|---|
| Reinforcement of air leak | Experimental | Device: Polyglycolic acid feltParticipants in this arm will receive reinforcement with the NEOVEIL (polyglycolic acid felt) which will be impregnated with human fibrinogen and thrombin. |
| No reinforcement of air leak | Active comparator | Other: Standard of careParticipants in this arm will receive standard of care for air leak post lung resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective lung resection at BMC
- Intra-operative diagnosis of air leak
Key exclusion criteria (1 listed)
- Patients undergoing emergency lung resection
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 |
|---|---|---|
| Polyglycolic acid feltAlso: NeoveilNeoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan. | Device | Reinforcement of air leak |
| Standard of careStandard of care after air leak post lung resection | Other | No reinforcement of air leak |
Primary outcome
Time to removal of chest tubes
Time frame: 2 years
The time in hours to removal of chest tubes post lung resection will be abstracted from the electronic medical record of each participant.
2 secondary outcomes
Length of hospital stay
Time frame: 2 years
Number of participants with additional interventions for air leak
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Kei Suzuki, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglycolic acid felt in people with Air Leak From Lung, run by Boston Medical Center at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 26 Aug 2020. 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to removal of chest tubes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2020.