Open ThoracotomyPhase 3NCT00748124
PleuraSeal Pivotal Study (US)
A Phase 3 study testing PleuraSeal Sealant System and Standard Tissue Closure Techniques in people with Open Thoracotomy, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Thoracotomy
- What is being tested?
- PleuraSeal Sealant System and Standard Tissue Closure Techniques
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2011
- Phase
- Phase 3
- 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
- Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.
- Conditions
- Open Thoracotomy
- Being tested
- PleuraSeal Sealant System, Standard Tissue Closure Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PleuraSeal Sealant SystemDevice
Lung Sealant Device + standard tissue closing techniques (sutures/staples)
Standard Tissue Closure TechniquesProcedure or surgery
Standard tissue closure techniques (sutures/ staples) alone
| Study group | Role | What they receive |
|---|---|---|
| PleuraSeal Sealant Device | Experimental | Not described Receives: Device: PleuraSeal Sealant System; Procedure: Standard Tissue Closure Techniques |
| Control | Other | Not described Receives: Procedure: Standard Tissue Closure Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
Measured: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2010
- Study completionApr 2011
Why it stopped: Interim analysis results were not supportive of primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open ThoracotomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748124
- Sponsor's protocol ID
- LUN-06-001
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2008
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
- ClinicalTrials.gov ID
- NCT00748124
- Acronym / sponsor ID
- LUN-06-001
- Conditions
- Open Thoracotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis results were not supportive of primary endpoint
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Sep 2008 (estimated)
- 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.
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PleuraSeal Sealant Device | Experimental | Device: PleuraSeal Sealant System, Procedure: Standard Tissue Closure Techniques |
| Control | Other | Procedure: Standard Tissue Closure Techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PleuraSeal Sealant SystemLung Sealant Device + standard tissue closing techniques (sutures/staples) | Device | PleuraSeal Sealant Device |
| Standard Tissue Closure TechniquesStandard tissue closure techniques (sutures/ staples) alone | Procedure or surgery | Control, PleuraSeal Sealant Device |
Primary outcome
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
Time frame: 75 days
Results and safety
The study was stopped early (reason given: Interim analysis results were not supportive of primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PleuraSeal Sealant System and Standard Tissue Closure Techniques in people with Open Thoracotomy, run by Integra LifeSciences Corporation 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 11 Sep 2014. 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.
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?
The study was stopped early (reason given: Interim analysis results were not supportive of primary endpoint). Results are not available in the source record.
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?
Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. (time frame: 75 days). 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 11 Sep 2014.