Lung DiseasesPhase 3NCT02511600
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
A Phase 3 study testing Progel Sealant, Talcum Powder and Pain Questionnaire in people with Lung Diseases and Mesothelioma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Mesothelioma
- What is being tested?
- Progel Sealant, Talcum Powder and Pain Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2018
- 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
- All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
- Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min
Who cannot join
- Patients unable to consent for the procedure
- Patients with a history of allergy to human proteins
- Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
About this study
Official title: A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.
Read the detailed description
If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.
At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.
Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:
- One group will have Progel® added to the surface of the lung before closing the chest.
- The other group will have talcum powder added to the surface of the lung before closing the chest.
Participant will have an equal chance of being in either group.
During the surgery, air leaks will be checked electronically and that information will be recorded.
After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.
Length of Study Participation:
After participant's surgery and their air leak is resolved, their participation in this study will be over.
This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.
Up to 48 participants will enrolled in this study. All will take part at MD Anderson.
- Conditions
- Lung Diseases, Mesothelioma
- Being tested
- Progel Sealant, Talcum Powder, Pain Questionnaire
- Keywords
- Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks, IAL
- Medical subject headings
- Lung Diseases, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progel SealantOther
After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
Talcum PowderOther
After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
Pain QuestionnaireBehavioural
Also called Survey
Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
| Study group | Role | What they receive |
|---|---|---|
| Progel Sealant | Experimental | After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital. Receives: Other: Progel Sealant; Behavioral: Pain Questionnaire |
| Standard of Care | Active comparator | After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital. Receives: Other: Talcum Powder; Behavioral: Pain Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolve Air Lung Leak After Pleurectomy Decortication
Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.
Measured: Participants followed for the duration of hospital stay, at least 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
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.
- More trials run by M.D. Anderson Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Incorporated
- Responsible party
- Sponsor
- Investigators
- Reza J. Mehran, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511600
- Sponsor's protocol ID
- 2014-0958
- Other IDs
- NCI-2015-01511
- Status last verified
- Dec 2015
- First submitted
- 28 Jul 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
- ClinicalTrials.gov ID
- NCT02511600
- Acronym / sponsor ID
- 2014-0958
- Conditions
- Lung Diseases, Mesothelioma
- Keywords
- Lung Diseases, Mesothelioma, Pleurectomy decortication, Progel, Talcum powder, Pain questionnaires, Surveys, Intraoperative air leaks
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bard Incorporated
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 30 Jul 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 goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.
Detailed description
If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.
At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.
Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:
- One group will have Progel® added to the surface of the lung before closing the chest.
- The other group will have talcum powder added to the surface of the lung before closing the chest.
Participant will have an equal chance of being in either group.
During the surgery, air leaks will be checked electronically and that information will be recorded.
After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.
Length of Study Participation:
After participant's surgery and their air leak is resolved, their participation in this study will be over.
This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.
Up to 48 participants will enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progel Sealant | Experimental | Other: Progel Sealant, Behavioral: Pain QuestionnaireAfter pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital. |
| Standard of Care | Active comparator | Other: Talcum Powder, Behavioral: Pain QuestionnaireAfter pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
- Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min
Key exclusion criteria (3 listed)
- Patients unable to consent for the procedure
- Patients with a history of allergy to human proteins
- Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
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 |
|---|---|---|
| Progel SealantAfter pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. | Other | Progel Sealant |
| Talcum PowderAfter pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. | Other | Standard of Care |
| Pain QuestionnaireAlso: SurveyParticipants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10. | Behavioural | Progel Sealant, Standard of Care |
Primary outcome
Time to Resolve Air Lung Leak After Pleurectomy Decortication
Time frame: Participants followed for the duration of hospital stay, at least 5 days.
Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.
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 15 Dec 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Reza J. Mehran, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progel Sealant, Talcum Powder and Pain Questionnaire in people with Lung Diseases and Mesothelioma, run by M.D. Anderson Cancer Center.
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 3 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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 Resolve Air Lung Leak After Pleurectomy Decortication (time frame: Participants followed for the duration of hospital stay, at least 5 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 15 Dec 2015.