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THOR IDE-studien (THOR)

2. november 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

155

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Thor Treatment

Treatment with the Thor system
Enhet: Thor laser atherectomy

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

Andre navn:
  • Thor kalsium modifikasjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Freedom from Major Adverse Events (MAEs)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Target lesion patency, 30 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Philips Clinical & Medical Affairs Global

Samarbeidspartnere

NAMSA
Syntropic

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. oktober 2024

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

7. juni 2023

Først innsendt som oppfylte QC-kriteriene

14. juni 2023

Først lagt ut (Faktiske)

23. juni 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 200201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere