Unruptured Intracranial AneurysmACCESSNCT05355259
ACtive Catheterization for EndovaScular TreatmentS
A study testing GECKO Active Guidewire in people with Unruptured Intracranial Aneurysm and Arteriovenous Cerebral Malformations, run by Basecamp Vascular at 1 site in France.
Trial summary
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations, Carotid Stenosis
- What is being tested?
- GECKO Active Guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to 5 Aug 2022
- Phase
- Interventional
- 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
- Male or female ≥18 years old.
- An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
- Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
- Subject is eligible to undergo a procedure with the use of contrast media.
- Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
- Subject has given written informed consent.
- Life expectancy >12 months.
Who cannot join
- Subject is unconscious and unable to directly provide his/her written informed consent.
- Subject with a type 3 aortic arch will be excluded from the study.
- Subject is or has been treated with radiation therapy to the neck or chest.
- Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
- Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
- Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
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- Subject is unable to complete the required follow-up.
- Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
- Subject has participated in a clinical study within the last 30 days.
- Subject with cardiac pacemaker or defibrillator.
- Persons under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACCESS : ACtive Catheterization for EndovaScular TreatmentS
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
Read the detailed description
The Basecamp Vascular trial is a prospective monocenter, non-randomized, open clinical investigation of their controllable directional GECKO guidewire which has not yet received the CE mark. The GECKO active guidewire is a sterile, single-use device to be used by interventional neuroradiologists (INR) to position a distal access catheter (DAC). The device is a system composed of a deflector (the guide) and a handle. The handle contains the battery and integrated electronics. The device can be activated using buttons on the handle. When the user presses a button, a current is transmitted along the guide to its end: this allows the guide to bend (two possible curves). The end of the device can then take an "S" shape. In INR, the placement of a DAC (at the cervical level) is the first step of an endovascular intervention (Primary Access). This is followed by the treatment phase of the vascular pathology with other medical devices (example: embolization, angioplasty). The GECKO active guide is a system that facilitates endovascular navigation and allows the positioning of the DAC via vascular access (femoral or radial artery). The GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments.
- Being tested
- GECKO Active Guidewire
- Keywords
- Active catheterization / guidewire, Endovascular treatments
- Medical subject headings
- Intracranial Arteriovenous Malformations, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GECKO Active GuidewireDevice
The GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments.
| Study group | Role | What they receive |
|---|---|---|
| GECKO Active Guidewire Use | Experimental | All patients will be treated using the GECKO guidewire to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion. Receives: Device: GECKO Active Guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative incidence of all adverse events (serious and non-serious)
The cumulative incidence of adverse events (serious and non-serious) related to the non-permanent implanted guidewire device or the procedure occurring from Day 1 to 30 days post-procedure. All Serious Adverse Events will be reported (e.g., any thromboembolic event [intracranial embolus in the targeted vessel territory or other territory, targeted vessel dissection or dissection of any catheterized vessel], major or minor stroke, or death within 30 days of the intervention).
Measured: 30 days
Secondary outcomes (7)
Number of successful GECKO guidewire placements at the target vessels
Technical success is defined as successful navigation, access and correct positioning of the guidewire and the distal access catheter at the target vessel. This will be measured by the number of successful GECKO guidewire placements at the target vessels.
Measured: During procedure
Measurement of the "time"
Measurement of the "time" to navigate the distal access catheter for Primary Access into the target vessel (time from femoral or radial puncture until arrival at the target vessel).
Measured: During procedure
GECKO Procedure Time
Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire.
Measured: During procedure
Overall Procedure Time
Defined as the time measured from the insertion of the groin or radial access sheath/catheter until the removal of the access sheath
Measured: During procedure
Number of participants with intracranial hemorrhage
Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic).
Measured: 30 Days
All-cause mortality.
All-cause mortality.
Measured: 30 Days
Devices Used
All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start27 Jun 2022
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective monocenter, non-randomized, open clinical investigation to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basecamp Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Piotin, M.D., Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355259
- Sponsor's protocol ID
- BCV-FIH-001
- Acronym
- ACCESS
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ; American College of Cardiology Foundation; American Stroke Association; American Association of Neurological Surgeons; American College of Radiology; American Society of Neuroradiology; Congress of Neurological Surgeons; Society of Atherosclerosis Imaging and Prevention; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of NeuroInterventional Surgery; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011 Jul 26;124(4):489-532. doi: 10.1161/CIR.0b013e31820d8d78. Epub 2011 Jan 31. No abstract available.
PubMed 21282505Lanzino G, Rabinstein AA, Brown RD Jr. Treatment of carotid artery stenosis: medical therapy, surgery, or stenting? Mayo Clin Proc. 2009 Apr;84(4):362-87; quiz 367-8. doi: 10.1016/S0025-6196(11)60546-6.
PubMed 19339655Jansen O, Szikora I, Causin F, Bruckmann H, Lobotesis K. Standards of practice in interventional neuroradiology. Neuroradiology. 2017 Jun;59(6):541-544. doi: 10.1007/s00234-017-1837-8. Epub 2017 May 19.
PubMed 28526977Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.
PubMed 26089327Smith TR, Cote DJ, Dasenbrock HH, Hamade YJ, Zammar SG, El Tecle NE, Batjer HH, Bendok BR. Comparison of the Efficacy and Safety of Endovascular Coiling Versus Microsurgical Clipping for Unruptured Middle Cerebral Artery Aneurysms: A Systematic Review and Meta-Analysis. World Neurosurg. 2015 Oct;84(4):942-53. doi: 10.1016/j.wneu.2015.05.073. Epub 2015 Jun 18.
PubMed 26093360Derdeyn CP, Zipfel GJ, Albuquerque FC, Cooke DL, Feldmann E, Sheehan JP, Torner JC; American Heart Association Stroke Council. Management of Brain Arteriovenous Malformations: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Aug;48(8):e200-e224. doi: 10.1161/STR.0000000000000134. Epub 2017 Jun 22.
PubMed 28642352Plasencia AR, Santillan A. Embolization and radiosurgery for arteriovenous malformations. Surg Neurol Int. 2012;3(Suppl 2):S90-S104. doi: 10.4103/2152-7806.95420. Epub 2012 Apr 26.
PubMed 22826821Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, Cao L, Fu Q, Wijeratne T, Leung TW, Montero-Baker M, Lee BC, Pircher S, Bosch M, Dennekamp M, Ringleb P. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015 Nov;46(11):3288-301. doi: 10.1161/STROKEAHA.115.003390. Epub 2015 Oct 8.
PubMed 26451020
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS : ACtive Catheterization for EndovaScular TreatmentS
- ClinicalTrials.gov ID
- NCT05355259
- Acronym / sponsor ID
- ACCESS / BCV-FIH-001
- Keywords
- Active catheterization / guidewire, Endovascular treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Basecamp VascularIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 2 May 2022 (actual)
- 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 objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
Detailed description
The Basecamp Vascular trial is a prospective monocenter, non-randomized, open clinical investigation of their controllable directional GECKO guidewire which has not yet received the CE mark. The GECKO active guidewire is a sterile, single-use device to be used by interventional neuroradiologists (INR) to position a distal access catheter (DAC). The device is a system composed of a deflector (the guide) and a handle. The handle contains the battery and integrated electronics. The device can be activated using buttons on the handle. When the user presses a button, a current is transmitted along the guide to its end: this allows the guide to bend (two possible curves). The end of the device can then take an "S" shape. In INR, the placement of a DAC (at the cervical level) is the first step of an endovascular intervention (Primary Access). This is followed by the treatment phase of the vascular pathology with other medical devices (example: embolization, angioplasty). The GECKO active guide is a system that facilitates endovascular navigation and allows the positioning of the DAC via vascular access (femoral or radial artery). The GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective monocenter, non-randomized, open clinical investigation to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
| Arm | Type | Receives |
|---|---|---|
| GECKO Active Guidewire Use | Experimental | Device: GECKO Active GuidewireAll patients will be treated using the GECKO guidewire to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 years old.
- An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
- Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
- Subject is eligible to undergo a procedure with the use of contrast media.
- Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
Key exclusion criteria (11 listed)
- Subject is unconscious and unable to directly provide his/her written informed consent.
- Subject with a type 3 aortic arch will be excluded from the study.
- Subject is or has been treated with radiation therapy to the neck or chest.
- Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
- Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
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 |
|---|---|---|
| GECKO Active GuidewireThe GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments. | Device | GECKO Active Guidewire Use |
Primary outcome
The cumulative incidence of all adverse events (serious and non-serious)
Time frame: 30 days
The cumulative incidence of adverse events (serious and non-serious) related to the non-permanent implanted guidewire device or the procedure occurring from Day 1 to 30 days post-procedure. All Serious Adverse Events will be reported (e.g., any thromboembolic event [intracranial embolus in the targeted vessel territory or other territory, targeted vessel dissection or dissection of any catheterized vessel], major or minor stroke, or death within 30 days of the intervention).
7 secondary outcomes
Number of successful GECKO guidewire placements at the target vessels
Time frame: During procedure
Measurement of the "time"
Time frame: During procedure
GECKO Procedure Time
Time frame: During procedure
Overall Procedure Time
Time frame: During procedure
Number of participants with intracranial hemorrhage
Time frame: 30 Days
All-cause mortality.
Time frame: 30 Days
Devices Used
Time frame: During procedure
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 3 Nov 2022.
- Background: PubMed 21282505Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ; American College of Cardiology Foundation; American Stroke Association; American Association of Neurological Surgeons; American College of Radiology; American Society of Neuroradiology; Congress of Neurological Surgeons; Society of Atherosclerosis Imaging and Prevention; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of NeuroInterventional Surgery; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011 Jul 26;124(4):489-532. doi: 10.1161/CIR.0b013e31820d8d78. Epub 2011 Jan 31. No abstract available.
- Background: PubMed 19339655Lanzino G, Rabinstein AA, Brown RD Jr. Treatment of carotid artery stenosis: medical therapy, surgery, or stenting? Mayo Clin Proc. 2009 Apr;84(4):362-87; quiz 367-8. doi: 10.1016/S0025-6196(11)60546-6.
- Results publication: PubMed 28526977Jansen O, Szikora I, Causin F, Bruckmann H, Lobotesis K. Standards of practice in interventional neuroradiology. Neuroradiology. 2017 Jun;59(6):541-544. doi: 10.1007/s00234-017-1837-8. Epub 2017 May 19.
- Results publication: PubMed 26089327Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.
- Results publication: PubMed 26093360Smith TR, Cote DJ, Dasenbrock HH, Hamade YJ, Zammar SG, El Tecle NE, Batjer HH, Bendok BR. Comparison of the Efficacy and Safety of Endovascular Coiling Versus Microsurgical Clipping for Unruptured Middle Cerebral Artery Aneurysms: A Systematic Review and Meta-Analysis. World Neurosurg. 2015 Oct;84(4):942-53. doi: 10.1016/j.wneu.2015.05.073. Epub 2015 Jun 18.
- Results publication: PubMed 28642352Derdeyn CP, Zipfel GJ, Albuquerque FC, Cooke DL, Feldmann E, Sheehan JP, Torner JC; American Heart Association Stroke Council. Management of Brain Arteriovenous Malformations: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Aug;48(8):e200-e224. doi: 10.1161/STR.0000000000000134. Epub 2017 Jun 22.
- Results publication: PubMed 22826821Plasencia AR, Santillan A. Embolization and radiosurgery for arteriovenous malformations. Surg Neurol Int. 2012;3(Suppl 2):S90-S104. doi: 10.4103/2152-7806.95420. Epub 2012 Apr 26.
- Results publication: PubMed 26451020Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, Cao L, Fu Q, Wijeratne T, Leung TW, Montero-Baker M, Lee BC, Pircher S, Bosch M, Dennekamp M, Ringleb P. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015 Nov;46(11):3288-301. doi: 10.1161/STROKEAHA.115.003390. Epub 2015 Oct 8.
- FDA Executive Summary General Issues: Meeting to Discuss the Evaluation of Safety and Effectiveness of Endovascular Medical Devices Intended to Treat Intracranial AneurysmsLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Michel Piotin, M.D. principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GECKO Active Guidewire in people with Unruptured Intracranial Aneurysm and Arteriovenous Cerebral Malformations, run by Basecamp Vascular at 1 site in France.
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 7 inclusion and 11 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 3 Nov 2022. 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 France. 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.
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 cumulative incidence of all adverse events (serious and non-serious) (time frame: 30 days). 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 NCT05355259, which also lists 8 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 3 Nov 2022.