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Studie THOR IDE (THOR)

2. listopadu 2026 aktualizováno: Philips Clinical & Medical Affairs Global

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).

The main question[s] it aims to answer are:

  • Is the Thor system safe in treating these lesions
  • Does the Thor system work to treat these lesions

Participants will:

  • Receive treatment with the Thor system
  • Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Up to 30 sites in the U.S. will be selected to do this study.

Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.

Patients will return for visits at 30 days, 6 months, and 12 months after the Thor procedure. At these visits patients will be asked questions about their medical history and medications taken for blood thinning or circulation, have a physical examination of their legs, have a test to check the blood flow in their treated leg (by checking arm and leg blood pressures), have an ultrasound of their treated leg, and be checked for any adverse events. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

It will take up to 24 months (2 years) to enroll all of the patients in the study. Patients who join the study will be in the study for about 12 months (1 year) and will have all of the visits with their doctor that they would normally have for their PAD.

Typ studie

Intervenční

Zápis (Odhadovaný)

155

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • California
      • St. Helena, California, Spojené státy, 94574
        • Staženo
        • St. Helena Hospital
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • Nábor
        • Rocky Mountain Regional VA Medical Center
        • Vrchní vyšetřovatel:
          • Bilal Aijaz, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Stephen Waldo, MD
        • Kontakt:
    • Florida
      • Bradenton, Florida, Spojené státy, 34205
      • Tallahassee, Florida, Spojené státy, 32308
        • Nábor
        • Tallahassee Research Institute
        • Vrchní vyšetřovatel:
          • William Dixon
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • John Katopodis
      • Winter Park, Florida, Spojené státy, 32792
        • Nábor
        • Guardian Research Organization
        • Vrchní vyšetřovatel:
          • Ashish Gupta, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Sandeep Bajaj
        • Kontakt:
          • Tiffany King
    • Iowa
      • Davenport, Iowa, Spojené státy, 52807
    • Louisiana
      • Houma, Louisiana, Spojené státy, 70360
        • Nábor
        • Cardiovascular Institute of the South
        • Vrchní vyšetřovatel:
          • Craig Walker, MD
        • Dílčí vyšetřovatel:
          • Matthew Finn, MD
        • Dílčí vyšetřovatel:
          • Pradeep Nair, MD
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • McCall Walker, MD
      • Lafayette, Louisiana, Spojené státy, 70503
        • Nábor
        • Cardiovascular Institute of the South
        • Vrchní vyšetřovatel:
          • Ankur Lodha, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Amit Amin, MD
        • Dílčí vyšetřovatel:
          • David Tadin, MD
    • Maine
      • Portland, Maine, Spojené státy, 04106
        • Nábor
        • The Vascular Care Group
        • Dílčí vyšetřovatel:
          • Todd Lancaster, MD
        • Dílčí vyšetřovatel:
          • Daniel Gorin, MD
        • Dílčí vyšetřovatel:
          • Christopher Kwolek, MD
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Nathan Aranson, MD
    • Massachusetts
      • Fall River, Massachusetts, Spojené státy, 02720
        • Nábor
        • Southcoast Hospitals/Charlton Memorial Hospital
        • Vrchní vyšetřovatel:
          • Richard Pin, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Mark Perry, MD
        • Dílčí vyšetřovatel:
          • Brandon Sumpio, MD
      • Leominster, Massachusetts, Spojené státy, 04153
        • Aktivní, ne nábor
        • Vascular Breakthroughs
    • Michigan
      • Detroit, Michigan, Spojené státy, 48202
        • Nábor
        • Henry Ford Hospital
        • Dílčí vyšetřovatel:
          • Pedro Villablanca, MD
        • Dílčí vyšetřovatel:
          • Khaldoon Alaswad, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Gerald Koenig, MD
        • Dílčí vyšetřovatel:
          • Vikas Aggarwal, MD
        • Dílčí vyšetřovatel:
          • Mohammad Alqarqaz, MD
        • Dílčí vyšetřovatel:
          • Herbert Aronow, MD
        • Vrchní vyšetřovatel:
          • Kyle Markel, MD
        • Kontakt:
      • Detroit, Michigan, Spojené státy, 22201
        • Nábor
        • Henry Ford St John Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Thomas Davis, Dr
        • Kontakt:
    • New Jersey
      • Browns Mills, New Jersey, Spojené státy, 08015
        • Nábor
        • Deborah Heart and Lung Center
        • Vrchní vyšetřovatel:
          • Richard Kovach, MD
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Gregory Domer, MD
      • New Brunswick, New Jersey, Spojené státy, 08901
        • Nábor
        • Heart and Vascular Institute of Central Jersey
        • Vrchní vyšetřovatel:
          • Ramzan Zakir, MD
        • Kontakt:
      • Vineland, New Jersey, Spojené státy, 08360
        • Nábor
        • Atlantic Medical Imaging of New jersey
        • Vrchní vyšetřovatel:
          • Micah Watts, MD
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Nicholas Petruzzi, MD
        • Dílčí vyšetřovatel:
          • Ramkrishna Patel, MD
    • New York
      • New York, New York, Spojené státy, 10029
        • Nábor
        • Mount Sinai Hospital
        • Vrchní vyšetřovatel:
          • Prakash Krishnan, MD
        • Dílčí vyšetřovatel:
          • David Song, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Vishal Kapur, MD
        • Dílčí vyšetřovatel:
          • Raman Sharma
        • Kontakt:
      • New York, New York, Spojené státy, 10029
        • Nábor
        • New York Presbyterian Hospital/Columbia University Irving Medical Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Virendra Patel, MD
        • Dílčí vyšetřovatel:
          • Thomas O'Donnell, MD
        • Dílčí vyšetřovatel:
          • Nicholas Morrissey
        • Dílčí vyšetřovatel:
          • Danielle Bajakian
        • Kontakt:
    • North Carolina
      • Cary, North Carolina, Spojené státy, 27518
        • Nábor
        • Vascular Solutions of North Carolina
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Sid Rao, MD
    • Ohio
      • Fairborn, Ohio, Spojené státy, 45324
        • Nábor
        • Premier Cardiovascular Institute
        • Vrchní vyšetřovatel:
          • Sagger Mawri, MD
        • Dílčí vyšetřovatel:
          • James Pan, MD
        • Kontakt:
        • Kontakt:
    • Oklahoma
      • Bartlesville, Oklahoma, Spojené státy, 74006
        • Nábor
        • Ascension St. John
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Anderson Merhle, MD
        • Dílčí vyšetřovatel:
          • Michael Megaly, MD
        • Kontakt:
          • Telefonní číslo: 918.332.3616
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, Spojené státy, 17050
        • Nábor
        • UPMC
        • Kontakt:
        • Vrchní vyšetřovatel:
          • William Bachinsky, Dr
        • Kontakt:
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • Nábor
        • Hospital of the University of Pennsylvania
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Elizabeth Genovese, MD
        • Dílčí vyšetřovatel:
          • Shang Loh, MD
        • Dílčí vyšetřovatel:
          • Alexander Fairman, MD
        • Dílčí vyšetřovatel:
          • Douglas Troutman, MD
      • Wynnewood, Pennsylvania, Spojené státy, 19096
        • Nábor
        • Lankenau Institute for Medical Research
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Antonis Pratsos, MD
        • Dílčí vyšetřovatel:
          • Manju Jayanna, MD
        • Dílčí vyšetřovatel:
          • Sarang Mangalmurti, MD
        • Kontakt:
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02905
        • Nábor
        • The Miriam Hospital
        • Vrchní vyšetřovatel:
          • Peter Soukas, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Pieter de Klerk, MD
    • Tennessee
      • Chattanooga, Tennessee, Spojené státy, 37421
        • Nábor
        • Vascular Institute of Chattanooga
        • Kontakt:
        • Dílčí vyšetřovatel:
          • William Harris, DO
        • Vrchní vyšetřovatel:
          • Chris LeSar, MD
    • Texas
      • Dallas, Texas, Spojené státy, 75390
      • Plano, Texas, Spojené státy, 75093
        • Nábor
        • Baylor, Scott & White, The Heart Hospital
        • Vrchní vyšetřovatel:
          • Sameh Sayfo, MD
        • Dílčí vyšetřovatel:
          • Chadi Dib, MD
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Tony Das, MD
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23507
        • Nábor
        • Sentara Health Research Center
        • Vrchní vyšetřovatel:
          • David Dexter, MD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Animesh Rathore, MD
        • Dílčí vyšetřovatel:
          • Priyam Vyas, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Patient age is ≥18 years
  • Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
  • Patient is able to walk unassisted or with non-motorized assistive devices
  • Patient has PAD with documented Rutherford Class 2-4 of the target limb
  • Anticipated life expectancy >12 months, in the opinion of the investigator at the time of enrollment.

Angiographic Inclusion Criteria:

  • Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
  • Target lesion has ≥70% diameter stenosis by investigator via visual assessment
  • Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
  • Chronic total occlusion lesion length is <100mm of the total ≤150mm target lesion
  • Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
  • Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
  • At least one patent tibial vessel (defined as <50% stenosis) with runoff to the foot
  • Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Exclusion Criteria:

  • Patient has active infection requiring antibiotic therapy
  • Stenting planned within the target lesion
  • Known positive for COVID-19 within the last 2 weeks and actively symptomatic
  • Pregnant (positive pregnancy test) or currently breast feeding
  • Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure
  • Cerebrovascular accident (CVA) <60 days prior to procedure
  • Myocardial infarction <60 days prior to procedure
  • History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
  • Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
  • Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
  • History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
  • Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure
  • Planned lower limb major amputation (above the ankle)
  • Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography
  • Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
  • The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion.

Angiographic Exclusion Criteria:

  • Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
  • Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Thor Treatment

Treatment with the Thor system
Přístroj: Thor laser atherectomy

Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Ostatní jména:
  • Thor modifikace vápníku

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Freedom from Major Adverse Events (MAEs)
Časové okno: 30 Days

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
30 Days
Procedural Success
Časové okno: At completion of the procedure

Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab
At completion of the procedure

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Target lesion patency, 30 days
Časové okno: 30 days

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
30 days
Target lesion patency, 6 months
Časové okno: 6 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
6 months
Target lesion patency, 12 months
Časové okno: 12 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
12 months
Clinically-driven target lesion revascularization
Časové okno: Through 12 months

Defined as repeat revascularization procedure of the target lesion if PSVR is ≥2.5 by DUS or if angiography shows a percent diameter stenosis >50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.
Through 12 months
Technical success
Časové okno: Peri-procedural

Defined as the ability to deliver the Thor system and achieve residual diameter stenosis ≤50% after treatment with Thor and prior to adjunctive PTA, as confirmed by independent core laboratory assessments of angiographic images
Peri-procedural
Frequency of peri-procedural adverse events
Časové okno: Within 24 hours of the procedure

Defined as frequency of adverse events related to the investigational device (Thor system)
Within 24 hours of the procedure
Adjunctive devices used with the Thor system
Časové okno: Peri-procedural

Defined as the use of other devices including angioplasty balloons, drug coated balloons, bailout stents, embolic filters
Peri-procedural
Target Limb Ankle-Brachial Index (ABI) change, Discharge
Časové okno: Discharge or up to 24 hours after the procedure

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at discharge compared to the baseline (Screening) value
Discharge or up to 24 hours after the procedure
Target Limb Ankle-Brachial Index (ABI) change, 30 days
Časové okno: 30 days

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 30 days compared to the baseline (Screening) value
30 days
Target Limb Ankle-Brachial Index (ABI) change, 6 months
Časové okno: 6 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 6 months compared to the baseline (Screening) value
6 months
Target Limb Ankle-Brachial Index (ABI) change, 12 months
Časové okno: 12 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 12 months compared to the baseline (Screening) value
12 months
Rutherford Classification change, 30 days
Časové okno: 30 days

Defined as the change in Rutherford classification at 30 days compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
30 days
Rutherford Classification change, 6 months
Časové okno: 6 months

Defined as the change in Rutherford classification at 6 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
6 months
Rutherford Classification change, 12 months
Časové okno: 12 months

Defined as the change in Rutherford classification at 12 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
12 months
Freedom from Major Adverse Events (MAEs)
Časové okno: Through 12 months

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Through 12 months
Change in Short Form Health Survey (SF-36) score, 30 days
Časové okno: 30 days

Defined as the change in SF-36 score at 30 days compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
30 days
Change in Short Form Health Survey (SF-36) score, 6 months
Časové okno: 6 months

Defined as the change in SF-36 score at 6 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
6 months
Change in Short Form Health Survey (SF-36) score, 12 months
Časové okno: 12 months

Defined as the change in SF-36 score at 12 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
12 months
Change in Walking Impairment Questionnaire (WIQ) score, 30 days
Časové okno: 30 days

Defined as the change in WIQ score at 30 days compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
30 days
Change in Walking Impairment Questionnaire (WIQ) score, 6 months
Časové okno: 6 months

Defined as the change in WIQ score at 6 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
6 months
Change in Walking Impairment Questionnaire (WIQ) score, 12 months
Časové okno: 12 months

Defined as the change in WIQ score at 12 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Philips Clinical & Medical Affairs Global

Spolupracovníci

NAMSA
Syntropic

Vyšetřovatelé

  • Vrchní vyšetřovatel: Elizabeth Genovese, MD, University of Pennsylvania
  • Vrchní vyšetřovatel: Pradeep Nair, MD, Cardiovascular Institute of the South (CIS)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

29. října 2024

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

7. června 2023

První předloženo, které splnilo kritéria kontroly kvality

14. června 2023

První zveřejněno (Aktuální)

23. června 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 200201

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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