Acute Coronary SyndromeEarly Phase 1EIRNCT02887768
Epicardial Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
A Early Phase 1 study testing Epicardial Infarct Repair with CorMatrix-ECM and Coronary Artery Bypass Grafting Surgery in people with Acute Coronary Syndrome and Heart Failure, run by University of Calgary at 1 site in Canada.
Trial summary
Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure
- What is being tested?
- Epicardial Infarct Repair with CorMatrix-ECM and Coronary Artery Bypass Grafting Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Oct 2017
- Phase
- Early Phase 1
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by ST changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- The patient is scheduled to undergo coronary artery bypass surgery within 6 weeks of the acute event.
- The patient does not possess any contraindication for CMR.
- The patient is greater then 35-years of age, English speaking, and capable of giving informed consent.
- The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Who cannot join
- The patient is over the age of 75 years.
- The patient has previous MI (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other LV territory.
- The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- The patient has undergone previous cardiac surgery.
- The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
Show all 13Show fewer
- The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
- The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
- The patient has a history of malignancy within the past year (other than squamous or basal cell carcinoma, which has been treated without evidence of recurrence).
- The patient has a recent history of drug or alcohol abuse.
- The patient has within 30-days of enrollment or is at anytime during this study participating in any other drug or device study.
- The patient has a known allergy to the CorMatrix-ECM material or any component of the material.
- Absence of non-viable myocardium within the LV on CMR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. This study will interrogate epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. Patients will be evaluated for markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance imaging (MRI). Adverse events will be monitored to ensure safety.
Read the detailed description
RATIONALE: Following ischemic injury the extracellular matrix (ECM) of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence suggests that the epicardial application of a healthy biologic ECM may reverse the adverse ECM remodeling that takes place following ischemic injury preventing LV dilatation and subsequent heart failure. The investigators have demonstrated that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. The investigators believe that epicardial infarct repair may not only restrain the infarcted myocardium to prevent infarct expansion and LV dilatation, but owing to it's biologic nature, help to provide a healthy ECM environment restoring ECM homeostasis and architecture. The investigators therefore propose clinical investigation epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. This is a patient population commonly referred for CABG surgery. While complete surgical revascularization can prevent further ischemic insult and salvage stunned or hibernating myocardium, it does not restore function to the infarcted myocardium resulting from the acute ischemic injury. The investigator's previous studies suggest that epicardial infarct repair as an adjunct to CABG surgery in this patient population may help improve myocardial function in this previously untreatable territory.
STUDY DESIGN: This is an open-label, non-randomized, feasibility pilot study
PRIMARY OBJECTIVE:
- To evaluate the feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI).
SECONDARY OBJECTIVES:
- To evaluate the feasibility of identifying the infarct area to be treated by epicardial infarct repair and measure regional function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
- To evaluate the safety of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery.
NUMBER OF SUBJECTS: Eight
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: CorMatrix-ECM will be surgically applied to the epicardial surface of the anterior LV wall at the time of coronary artery bypass surgery.
CONTROL PRODUCT, DOSE AND ROUTE OF ADMINISTRATION: No control group will be performed in this pilot trial.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY: Subjects will be involved in the study for up to 6 months.
Screening/Enrollment: 0-6 weeks between acute coronary syndrome presentation and CABG surgery.
Treatment: Day of CABG surgery. Follow-up: 6 months postoperatively. Total duration of the study is expected to be 9 months. Three months for subject enrollment and 6 months for final subject follow-up.
CONCOMMITANT MEDICATIONS:
Prohibited: Immunosuppressive medications (including steroids). Allowed: Any other medications.
FEASIBILITY EVALUATIONS: Feasibility will be accessed through qualitative evaluation by the performing surgeon and successful measurement of cardiac function and tissue characterization by CMR.
PRIMARY ENDPOINT:
- Feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI) evaluated by the performing surgeon though qualitative observation.
SECONDARY ENDPOINTS:
- Feasibility of measuring regional myocardial function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
- The safety of epicardial infarct repair performed with CorMatrix-ECM.
SAFETY EVALUATIONS :
Adverse events including: all cause mortality; cardiovascular mortality; MACCE; major bleeding events; primary surgical site infection; and myocardial constriction will be recorded.
RATIONALE FOR NUMBER OF STUDY SUBJECTS: This is a pilot study designed to access the feasibility of performing epicardial infarct repair with CorMatrix-ECM in subacute MI patients going for CABG surgery, the feasibility of measuring cardiac function and various tissue characteristics within the treated myocardium by CMR in this patient population, and the safety of epicardial infarct repair performed at the time of CABG surgery. Given the preliminary nature of this study 8 subjects will be tested to confirm feasibility and inform future randomized control trial study design.
- Conditions
- Acute Coronary Syndrome, Heart Failure
- Being tested
- Epicardial Infarct Repair with CorMatrix-ECM, Coronary Artery Bypass Grafting Surgery
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial Infarct Repair with CorMatrix-ECMDevice
Also called SIS-ECM (small intestine submucosa extracellular matrix)
CorMatrix-ECM-biomaterial will be surgically applied to the epicardial surface of the infarct myocardium at the time of coronary artery bypass surgery
Coronary Artery Bypass Grafting SurgeryProcedure or surgery
Also called Aorto-coronary bypass surgery
All participants will undergo standard coronary artery bypass grafting surgery to treat coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Epicardial Infarct Repair with CorMatrix-ECM in addition to coronary artery bypass grafting Receives: Device: Epicardial Infarct Repair with CorMatrix-ECM; Procedure: Coronary Artery Bypass Grafting Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients in which the study intervention is successfully completed
Feasibility will be accessed through qualitative evaluation by the performing surgeon. Successful application of CorMatrix-ECM to the infarcted myocardium at the time of coronary artery bypass grafting surgery will be deemed as successful completion of the study intervention.
Measured: 6 weeks
Secondary outcomes (3)
The number of patients in which the target myocardium can be successfully identified at the time of surgery
The infarct area will be identified by CMR using a standard late gadolinium enhancement protocol and the feasibility of correlating the CMR images with the surgical anatomy will be qualitatively evaluated by the performing surgeon.
Measured: 6 weeks
The number of patients in which regional myocardial function and tissue characteristics are successfully measured by CMR
The feasibility of evaluating both regional function and tissue characteristics will be confirmed by successful measurement of left ventricular volume, ejection fraction, regional wall motion, myocardial edema, myocardial fibrosis, myocardial tissue viability and myocardial strain using cardiac magnetic resonance (CMR).
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Corvivo Cardiovascular, Inc.
- Responsible party
- Principal investigator, Dr. Paul Fedak, University of Calgary
- Investigators
- Paul WM Fedak, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887768
- Sponsor's protocol ID
- REB14-1715
- Acronym
- EIR
- Status last verified
- Oct 2017
- First submitted
- 2 Apr 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual patient data will only be shared with that patient. De-identified and compiled data will be used for analysis and publication.
Publications
Mewhort HE, Turnbull JD, Satriano A, Chow K, Flewitt JA, Andrei AC, Guzzardi DG, Svystonyuk DA, White JA, Fedak PW. Epicardial infarct repair with bioinductive extracellular matrix promotes vasculogenesis and myocardial recovery. J Heart Lung Transplant. 2016 May;35(5):661-70. doi: 10.1016/j.healun.2016.01.012. Epub 2016 Jan 15.
PubMed 26987597Mewhort HE, Turnbull JD, Meijndert HC, Ngu JM, Fedak PW. Epicardial infarct repair with basic fibroblast growth factor-enhanced CorMatrix-ECM biomaterial attenuates postischemic cardiac remodeling. J Thorac Cardiovasc Surg. 2014 May;147(5):1650-9. doi: 10.1016/j.jtcvs.2013.08.005. Epub 2013 Sep 26.
PubMed 24075463
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT02887768
- Acronym / sponsor ID
- EIR / REB14-1715
- Conditions
- Acute Coronary Syndrome, Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Corvivo Cardiovascular, Inc.
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Sep 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.
Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. This study will interrogate epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. Patients will be evaluated for markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance imaging (MRI). Adverse events will be monitored to ensure safety.
Detailed description
RATIONALE: Following ischemic injury the extracellular matrix (ECM) of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence suggests that the epicardial application of a healthy biologic ECM may reverse the adverse ECM remodeling that takes place following ischemic injury preventing LV dilatation and subsequent heart failure. The investigators have demonstrated that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. The investigators believe that epicardial infarct repair may not only restrain the infarcted myocardium to prevent infarct expansion and LV dilatation, but owing to it's biologic nature, help to provide a healthy ECM environment restoring ECM homeostasis and architecture. The investigators therefore propose clinical investigation epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. This is a patient population commonly referred for CABG surgery. While complete surgical revascularization can prevent further ischemic insult and salvage stunned or hibernating myocardium, it does not restore function to the infarcted myocardium resulting from the acute ischemic injury. The investigator's previous studies suggest that epicardial infarct repair as an adjunct to CABG surgery in this patient population may help improve myocardial function in this previously untreatable territory.
STUDY DESIGN: This is an open-label, non-randomized, feasibility pilot study
PRIMARY OBJECTIVE:
- To evaluate the feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI).
SECONDARY OBJECTIVES:
- To evaluate the feasibility of identifying the infarct area to be treated by epicardial infarct repair and measure regional function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
- To evaluate the safety of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery.
NUMBER OF SUBJECTS: Eight
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: CorMatrix-ECM will be surgically applied to the epicardial surface of the anterior LV wall at the time of coronary artery bypass surgery.
CONTROL PRODUCT, DOSE AND ROUTE OF ADMINISTRATION: No control group will be performed in this pilot trial.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY: Subjects will be involved in the study for up to 6 months.
Screening/Enrollment: 0-6 weeks between acute coronary syndrome presentation and CABG surgery.
Treatment: Day of CABG surgery. Follow-up: 6 months postoperatively. Total duration of the study is expected to be 9 months. Three months for subject enrollment and 6 months for final subject follow-up.
CONCOMMITANT MEDICATIONS:
Prohibited: Immunosuppressive medications (including steroids). Allowed: Any other medications.
FEASIBILITY EVALUATIONS: Feasibility will be accessed through qualitative evaluation by the performing surgeon and successful measurement of cardiac function and tissue characterization by CMR.
PRIMARY ENDPOINT:
- Feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI) evaluated by the performing surgeon though qualitative observation.
SECONDARY ENDPOINTS:
- Feasibility of measuring regional myocardial function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
- The safety of epicardial infarct repair performed with CorMatrix-ECM.
SAFETY EVALUATIONS :
Adverse events including: all cause mortality; cardiovascular mortality; MACCE; major bleeding events; primary surgical site infection; and myocardial constriction will be recorded.
RATIONALE FOR NUMBER OF STUDY SUBJECTS: This is a pilot study designed to access the feasibility of performing epicardial infarct repair with CorMatrix-ECM in subacute MI patients going for CABG surgery, the feasibility of measuring cardiac function and various tissue characteristics within the treated myocardium by CMR in this patient population, and the safety of epicardial infarct repair performed at the time of CABG surgery. Given the preliminary nature of this study 8 subjects will be tested to confirm feasibility and inform future randomized control trial study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Epicardial Infarct Repair with CorMatrix-ECM, Procedure: Coronary Artery Bypass Grafting SurgeryEpicardial Infarct Repair with CorMatrix-ECM in addition to coronary artery bypass grafting |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by ST changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- The patient is scheduled to undergo coronary artery bypass surgery within 6 weeks of the acute event.
- The patient does not possess any contraindication for CMR.
- The patient is greater then 35-years of age, English speaking, and capable of giving informed consent.
- The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Key exclusion criteria (13 listed)
- The patient is over the age of 75 years.
- The patient has previous MI (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other LV territory.
- The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- The patient has undergone previous cardiac surgery.
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 |
|---|---|---|
| Epicardial Infarct Repair with CorMatrix-ECMAlso: SIS-ECM (small intestine submucosa extracellular matrix)CorMatrix-ECM-biomaterial will be surgically applied to the epicardial surface of the infarct myocardium at the time of coronary artery bypass surgery | Device | Treatment |
| Coronary Artery Bypass Grafting SurgeryAlso: Aorto-coronary bypass surgeryAll participants will undergo standard coronary artery bypass grafting surgery to treat coronary artery disease | Procedure or surgery | Treatment |
Primary outcome
The number of patients in which the study intervention is successfully completed
Time frame: 6 weeks
Feasibility will be accessed through qualitative evaluation by the performing surgeon. Successful application of CorMatrix-ECM to the infarcted myocardium at the time of coronary artery bypass grafting surgery will be deemed as successful completion of the study intervention.
3 secondary outcomes
The number of patients in which the target myocardium can be successfully identified at the time of surgery
Time frame: 6 weeks
The number of patients in which regional myocardial function and tissue characteristics are successfully measured by CMR
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
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 30 Oct 2017.
- Results publication: PubMed 26987597Mewhort HE, Turnbull JD, Satriano A, Chow K, Flewitt JA, Andrei AC, Guzzardi DG, Svystonyuk DA, White JA, Fedak PW. Epicardial infarct repair with bioinductive extracellular matrix promotes vasculogenesis and myocardial recovery. J Heart Lung Transplant. 2016 May;35(5):661-70. doi: 10.1016/j.healun.2016.01.012. Epub 2016 Jan 15.
- Results publication: PubMed 24075463Mewhort HE, Turnbull JD, Meijndert HC, Ngu JM, Fedak PW. Epicardial infarct repair with basic fibroblast growth factor-enhanced CorMatrix-ECM biomaterial attenuates postischemic cardiac remodeling. J Thorac Cardiovasc Surg. 2014 May;147(5):1650-9. doi: 10.1016/j.jtcvs.2013.08.005. Epub 2013 Sep 26.
- Individual participant dataSharing planned: Yes. Individual patient data will only be shared with that patient. De-identified and compiled data will be used for analysis and publication.
Related trials for Acute Coronary Syndrome
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
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.
Paul WM Fedak, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Epicardial Infarct Repair with CorMatrix-ECM and Coronary Artery Bypass Grafting Surgery in people with Acute Coronary Syndrome and Heart Failure, run by University of Calgary at 1 site in Canada.
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 13 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 30 Oct 2017. 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 Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The number of patients in which the study intervention is successfully completed (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02887768, which also lists 2 linked publications.
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 30 Oct 2017.