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De THOR IDE-studie (THOR)

2 november 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

155

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Thor Treatment

Treatment with the Thor system
Apparaat: Thor laser atherectomy

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

Andere namen:
  • Thor calcium modificatie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Freedom from Major Adverse Events (MAEs)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Target lesion patency, 30 days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Philips Clinical & Medical Affairs Global

Medewerkers

NAMSA
Syntropic

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 oktober 2024

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

7 juni 2023

Eerst ingediend dat voldeed aan de QC-criteria

14 juni 2023

Eerst geplaatst (Werkelijk)

23 juni 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 200201

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren