- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05893719
Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT (SEMTiC)
First Prospective, Single-arm, Multicentre Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT in Patients With Acute Ischemic Stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research.
The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well).
Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Kortrijk, Belgium
- Not yet recruiting
- Hospital AZ Groeninge
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Contact:
- François
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Olivier François
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Bordeaux, France
- Not yet recruiting
- Hospital Universitario CHU Bordeaux
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Contact:
- Barreau
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Xavier Barreau
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Paris, France
- Not yet recruiting
- Hospital BICETRE
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Contact:
- Spelle
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Laurent Spelle
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Ludwigsburg, Germany, 71640
- Not yet recruiting
- Hospital Klinikum Ludwigsburg
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Contact:
- Meckel
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Stephan Meckel
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Munich, Germany, 80336
- Not yet recruiting
- Hospital LMU Klinikum
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Contact:
- Liebig
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Thomas Liebig
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Nürnberg, Germany, 90471
- Not yet recruiting
- Hospital Klinikum Nürnberg
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Contact:
- Holtmannspöetter
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Markus Holtmannspöetter
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Alicante, Spain, 03010
- Recruiting
- Hospital General Universitario de Alicante
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Contact:
- Domínguez
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Carlos Domínguez
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Badajoz, Spain, 06080
- Recruiting
- Hospital Universitario de Badajoz
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Contact:
- Fernández-Prudencio
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Luis Fernández-Prudencio
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Baracaldo, Spain, 48903
- Recruiting
- Hospital De Cruces
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Contact:
- González
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Eva González
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Barcelona, Spain, 08907
- Recruiting
- Hospital Universitario de Bellvitge
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Contact:
- Chirife
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Oscar Chirife
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic i Provincial de Barcelona
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Contact:
- López
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Antonio López
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Barcelona, Spain, 08035
- Recruiting
- Hospital de la Vall d'Hebron
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Contact:
- Tomasello
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Alejandro Tomasello
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Barcelona, Spain, 08916
- Recruiting
- Hospital GermansTrias i Pujol
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Contact:
- Castaño
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Carlos Castaño
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Córdoba, Spain, 14004
- Recruiting
- Hospital Reina Sofía de Córdoba
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Contact:
- Delgado
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Fernando Delgado
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Las Palmas De Gran Canaria, Spain, 35016
- Recruiting
- Hospital Insular de Gran Canaria
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Contact:
- Aguilar
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Yeray Aguilar
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Madrid, Spain, 28040
- Recruiting
- Hospital Clinico San Carlos
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Contact:
- Moreu
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Manuel Moreu
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Contact:
- Castro
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Enrique Castro
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Valencia, Spain, 46010
- Recruiting
- Hospital Clinico de Valencia
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Contact:
- Gil
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Joaquin Gil
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Valencia, Spain, 46026
- Recruiting
- Hospital la Fe
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Contact:
- Aparici
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Fernando Aparici
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Asturias
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Oviedo, Asturias, Spain, 33011
- Recruiting
- Hospital Universitario Central de Asturias
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Contact:
- Vega
- Phone Number: +34 936724711
- Email: clinica@ivascular.global
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Principal Investigator:
- Pedro Vega
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Clinical:
- Age ≥18
- Informed consent signed by the patient or their representative; to use the patient's data
- Focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points.
- Pre-stroke mRS score ≤2.
- Planning to start treatment within 8 hours of symptoms onset, defined as the last time when the patient was seen well (the start of the procedure is defined as arterial puncture).
Neuroimaging criteria:
- Occlusion (TICI 0 or TICI 1) of the internal intracranial carotid artery, M1 and M2 segments of the middle cerebral artery and T carotid artery, suitable for mechanical thrombectomy confirmed by conventional angiography.
For patients treated ≤8 hours:
a) Score 6 to 10 on ASPECTS scale (Alberta Stroke Program Early CT Score).
For patients treated between 8 and 24 hours:
a) "Target Mismatch Profile" on CT perfusion or MRI (ischemic core volume is <70mL, mismatch ratio is >1,8 and mismatch volume is >15 mL).
- Ability to obtain selective angiography by catheterisation of the target artery.
Exclusion Criteria:
Clinical:
- Initially treated with a different thrombectomy device in the same procedure.
- Patient has suffered a stroke in the past one year.
- Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0.
- Blood glucose <50 mg/dl or >400 mg/dl. NOTE: If blood glucose can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines, the patient may be included.
- Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). NOTE: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.
- Serious advanced or terminal illness with anticipated life expectancy of less than six months.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known allergy to nickel, prior to treatment.
- Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
- Cerebral vasculitis.
- Known current cocaine use.
- Patient who is participating, at the time of inclusion, in a study with a device or drug that could affect this study.
- Patients who are unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitors from overseas).
Neuroimaging criteria:
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- Significant mass effect with midline shift.
- Evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery (TANDEM lesions).
- Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
- Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation or anterior/posterior circulation).
- Evidence of intracranial tumour with the exception of asymptomatic meningiomas with no mass effect.
- Presumed septic embolism with suspected aortic dissection or suspicion of bacterial endocarditis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental: iNedit, iNdeep, iNtercept
Study devices
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Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 90 days
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All-cause mortality
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90 days
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Performance Success
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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To assess the ability of the system to successfully perform a neurothrombectomy using the three devices to be evaluated and with ≤3 insertions (passes) of the stent retriever.
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In the course of endovascular procedure, evaluated immediately after it.
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MAE
Time Frame: 24 hours (-8/+12 h)
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All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.
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24 hours (-8/+12 h)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical progress
Time Frame: 90 days
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Good functional clinical progress (modified Rankin scale 0-2)
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90 days
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Proportion of patients with rapid neurological improvement
Time Frame: 24 hours after treatment
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Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS ≤4)
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24 hours after treatment
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Reduction of NIHSS scale
Time Frame: At 72 hours or at the time of discharge, whichever occurs first.
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Proportion of patients with a reduction of ≥8 points on the NIHSS scale or NIHSS 0-1
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At 72 hours or at the time of discharge, whichever occurs first.
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Procedure duration
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram.
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In the course of endovascular procedure, evaluated immediately after it.
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Number of passes with the device until recanalization.
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Number of passes with the device until recanalization.
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In the course of endovascular procedure, evaluated immediately after it.
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Percentage of effective recanalization in a first pass.
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Percentage of effective recanalization in a first pass.
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In the course of endovascular procedure, evaluated immediately after it.
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Rate of cases that reached the occlusion and allowed the performance of the trombectomy.
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Rate of cases where the microcatheter and the distal access balloon catheter reached the occlusion in the main vessel to allow navigation and deployment of the stent retriever to carry out the neurothrombectomy.
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In the course of endovascular procedure, evaluated immediately after it.
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Assessment of intracranial haemorrhage (ICH)
Time Frame: 24 (-8/+12) hours
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Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT).
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24 (-8/+12) hours
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Neurological deterioration
Time Frame: 24 (-8/+12) hours.
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Classification of neurological deterioration of ≥4 points on the NIHSS scale
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24 (-8/+12) hours.
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Embolization rate
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Embolization rate in a previously non-involved territory on cerebral angiography.
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In the course of endovascular procedure, evaluated immediately after it.
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Mortality rate
Time Frame: 3 days (+/-24) hours
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Mortality rate related to the procedure
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3 days (+/-24) hours
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Procedure complication rate
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
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Procedure complication rate: arterial perforation, arterial dissection and vasospasm in the target vessel and embolization in a previously non-involved vascular territory.
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In the course of endovascular procedure, evaluated immediately after it.
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Rate of infarction in a previously non-involved vascular territory
Time Frame: 24 hours.
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Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT).
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24 hours.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEMTiC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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