Thoracic Surgery LungPhase 2HemopatchNCT02364791
A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures
A Phase 2 study testing Hemopatch in people with Thoracic Surgery Lung and Post-operative Thoracic Air Leak, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery Lung, Post-operative Thoracic Air Leak
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Dec 2024
- Phase
- Phase 2
- 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
- Age ≥18 years
- High risk of prolonged air leak due to at least one of the following reasons:
- Preoperative FEV1<80%
- DLco < 80%
- LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
- Anticipation of intraoperative adhesions (ie, redo surgery)
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- Previous induction chemotherapy for locally advanced NSCLC
- Chronic steroid use
- Pleural mesothelioma
- Candidate to one of the following major thoracic surgical intervention:
- Decortication
- Reintervention on the same side of the previous intervention
- Segmentectomy
- Lobectomy with incomplete fissures on CT scan
- Written informed consent.
Who cannot join
- Pregnancy or breast-feeding
- Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
- Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
- Known hypersensitivity to bovine proteins or brilliant blue (FD\&C Blue No.1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).
The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.
- Being tested
- standard techniques used to achieve air leak control, Hemopatch
- Keywords
- pulmonary resection, chest tube, segmentectomy, lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard techniques used to achieve air leak controlDevice
HemopatchDevice
Also called sealing hemostat
| Study group | Role | What they receive |
|---|---|---|
| standard treatment | Active comparator | standard techniques to achieve air leak control after complex thoracic surgical procedures Receives: Device: standard techniques used to achieve air leak control |
| standard treatment plus hemopatch | Experimental | the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures Receives: Device: standard techniques used to achieve air leak control; Device: Hemopatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days from time of extubation to time of drainage tube removal
Measured: up to 7 days
Secondary outcomes (4)
number of days to end of air leak
air leak measure are recorded every 6 hours
Measured: up to 7 days
worst grade toxicity per patient
according to Common Terminology Criteria for Adverse Events version 4.0
Measured: up to 6 weeks
change in quality of life
Measured: baseline, one week, one month
number of days from surgical intervention to patient discharge
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery LungStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Clinico Humanitas, European Institute of Oncology, Regina Elena Cancer Institute, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Gaetano Rocco, MD, FRCSEd, Principal investigator, National Cancer Institute, NaplesFrancesco Perrone, MD, PhD, Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364791
- Sponsor's protocol ID
- Hemopatch
- Acronym
- Hemopatch
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2015
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).
- ClinicalTrials.gov ID
- NCT02364791
- Acronym / sponsor ID
- Hemopatch / Hemopatch
- Keywords
- pulmonary resection, chest tube, segmentectomy, lobectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Clinico Humanitas, European Institute of Oncology, Regina Elena Cancer Institute, Baxter Healthcare Corporation
- Study start
- Feb 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Feb 2015 (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 purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment | Active comparator | Device: standard techniques used to achieve air leak controlstandard techniques to achieve air leak control after complex thoracic surgical procedures |
| standard treatment plus hemopatch | Experimental | Device: standard techniques used to achieve air leak control, Device: Hemopatchthe addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years
- High risk of prolonged air leak due to at least one of the following reasons:
- Candidate to one of the following major thoracic surgical intervention:
- Written informed consent.
Key exclusion criteria (4 listed)
- Pregnancy or breast-feeding
- Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
- Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
- Known hypersensitivity to bovine proteins or brilliant blue (FD\&C Blue No.1)
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 |
|---|---|---|
| standard techniques used to achieve air leak control | Device | standard treatment, standard treatment plus hemopatch |
| HemopatchAlso: sealing hemostat | Device | standard treatment plus hemopatch |
Primary outcome
number of days from time of extubation to time of drainage tube removal
Time frame: up to 7 days
4 secondary outcomes
number of days to end of air leak
Time frame: up to 7 days
worst grade toxicity per patient
Time frame: up to 6 weeks
change in quality of life
Time frame: baseline, one week, one month
number of days from surgical intervention to patient discharge
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Gaetano Rocco, MD, FRCSEd principal investigator
National Cancer Institute, Naples
Francesco Perrone, MD, PhD principal investigator
National Cancer Institute, Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemopatch in people with Thoracic Surgery Lung and Post-operative Thoracic Air Leak, run by National Cancer Institute, Naples at 1 site in Italy.
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 15 inclusion and 4 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 24 Mar 2023. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
number of days from time of extubation to time of drainage tube removal (time frame: up to 7 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 24 Mar 2023.