LUNG DISEASESPhase 4NCT02668978
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH
A Phase 4 study testing Hemopatch™ Sealing Hemostat and Standard surgical technique in people with LUNG DISEASES, run by Quirón Madrid University Hospital at 1 site in Spain.
Trial summary
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LUNG DISEASES
- What is being tested?
- Hemopatch™ Sealing Hemostat and Standard surgical technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to 31 Aug 2019
- Phase
- Phase 4
- 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 over the age of 18 years who are able to give their informed consent
- Patients undergoing lung resection surgery for either malignant or benign conditions including:
- Lobar and sublobar resections
- Open, video-assisted thoracoscopic or robotic surgeries
- Diagnostic or therapeutic procedures
Who cannot join
- Traumatic pulmonary contusion or laceration
- Lung reduction surgery
- Planned removal of more than 10 lung lesions
- Pneumonectomy
- Known hypersensitivity to bovine protein
- Known hypersensitivity to Brilliant Blue FCF (E133)
- Presence of active infection
Trial locations and contacts
1 site in 1 country.
Spain1 site
Quirónsalud Madrid University Hospital
Pozuelo de Alarcón, Madrid, 280222
About this study
Official title: Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.
Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."
- Conditions
- LUNG DISEASES
- Being tested
- Hemopatch™ Sealing Hemostat, Standard surgical technique
- Keywords
- lung surgery, air leak, prevention
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemopatch™ Sealing HemostatDevice
Hemopatch™ application over lung resection areas
Standard surgical techniqueProcedure or surgery
Lung resuturing or restapling
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch™ | Experimental | Hemopatch™ sealing hemostat Receives: Device: Hemopatch™ Sealing Hemostat |
| Control | Active comparator | Standard surgical technique Receives: Procedure: Standard surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative air leaks
Duration of postoperative lung air leaks expressed in hours
Measured: Within first 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUNG DISEASESStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quirón Madrid University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter BioScience
- Responsible party
- Principal investigator, Javier MORADIELLOS, Quirón Madrid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668978
- Sponsor's protocol ID
- SEALLS
- Status last verified
- Aug 2019
- First submitted
- 27 Jan 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
- ClinicalTrials.gov ID
- NCT02668978
- Acronym / sponsor ID
- SEALLS
- Conditions
- LUNG DISEASES
- Keywords
- lung surgery, air leak, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Quirón Madrid University HospitalUniversity, hospital or other
- Collaborators
- Baxter BioScience
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 Jan 2016 (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.
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques.
Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemopatch™ | Experimental | Device: Hemopatch™ Sealing HemostatHemopatch™ sealing hemostat |
| Control | Active comparator | Procedure: Standard surgical techniqueStandard surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over the age of 18 years who are able to give their informed consent
- Patients undergoing lung resection surgery for either malignant or benign conditions including:
Key exclusion criteria (7 listed)
- Traumatic pulmonary contusion or laceration
- Lung reduction surgery
- Planned removal of more than 10 lung lesions
- Pneumonectomy
- Known hypersensitivity to bovine protein
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 |
|---|---|---|
| Hemopatch™ Sealing HemostatHemopatch™ application over lung resection areas | Device | Hemopatch™ |
| Standard surgical techniqueLung resuturing or restapling | Procedure or surgery | Control |
Primary outcome
Duration of postoperative air leaks
Time frame: Within first 30 postoperative days
Duration of postoperative lung air leaks expressed in hours
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 4 Sep 2019.
- 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.
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 4 study testing Hemopatch™ Sealing Hemostat and Standard surgical technique in people with LUNG DISEASES, run by Quirón Madrid University Hospital at 1 site in Spain.
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 5 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 4 Sep 2019. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Duration of postoperative air leaks (time frame: Within first 30 postoperative 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 4 Sep 2019.