Undersøgelse af langsigtet sikkerhed og resultater af behandling af lungeemboli med Indigo Aspiration System
3. november 2026 opdateret af: Penumbra Inc.
STRIKE-PE: En prospektiv, multicenter undersøgelse af Indigo™ aspirationssystemet, der søger at evaluere den langsigtede sikkerhed og resultaterne af behandling af lungeemboli
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Joanne Krasnoff
- Telefonnummer: 650-455-4462
- E-mail: jkrasnoff@penumbrainc.com
Undersøgelse Kontakt Backup
- Navn: Aisha Pascua
- Telefonnummer: 415-601-9561
- E-mail: apascua@penumbrainc.com
Studiesteder
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New South Wales
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Westmead, New South Wales, Australien, 2145
- Rekruttering
- Westmead Hospital
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South Australia
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Bedford Park, South Australia, Australien, 5043
- Rekruttering
- Flinders Medical Centre
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Brasília, Brasilien, 70390-700
- Rekruttering
- Hospital Santa Lucia Sul
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London, Det Forenede Kongerige, NW3 2QG
- Rekruttering
- Royal Free Hospital
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Sussex
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Brighton, Sussex, Det Forenede Kongerige, BN2 5BE
- Rekruttering
- Royal Sussex County Hospital
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Wales
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Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
- Afsluttet
- University Hospital of Wales
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California
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Long Beach, California, Forenede Stater, 90806
- Rekruttering
- Long Beach Medical Center
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Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Cedars-Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Medical Center
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Orange, California, Forenede Stater, 92868
- Rekruttering
- UC Irvine Medical Center
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- Sharp Memorial Hospital
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San Diego, California, Forenede Stater, 92037
- Rekruttering
- UCSD Jacobs
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Rekruttering
- Christiana Care Hospital
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Rekruttering
- MedStar Washington Hospital Center
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Florida
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Bradenton, Florida, Forenede Stater, 34205
- Rekruttering
- Manatee Memorial Hospital
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Brandenton, Florida, Forenede Stater, 34209
- Rekruttering
- Blake Medical Center/Nova Clinical Research
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Delray Beach, Florida, Forenede Stater, 33484
- Rekruttering
- Delray Medical Center, Inc.
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Gainesville, Florida, Forenede Stater, 32608
- Rekruttering
- University of Florida Shands Hospital
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Lakeland, Florida, Forenede Stater, 33805
- Rekruttering
- Radiology and Imaging Specialists
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- Jackson Memorial Hospital
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- Baptist Health Miami Cardiac and Vascular Institute
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- AdventHealth Orlando
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Petersburg, Florida, Forenede Stater, 33709
- Rekruttering
- HCA Florida Northside Hospital
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Tampa, Florida, Forenede Stater, 33606
- Rekruttering
- Tampa General Hospital
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Tampa, Florida, Forenede Stater, 33614
- Rekruttering
- St. Joseph Hospital - BayCare
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Georgia
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Augusta, Georgia, Forenede Stater, 30901
- Rekruttering
- University Hospital Augusta
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Illinois
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Belleville, Illinois, Forenede Stater, 62226
- Rekruttering
- Memorial Hospital Belleville
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Glenview, Illinois, Forenede Stater, 60026
- Rekruttering
- Glenbrook Hospital
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Maywood, Illinois, Forenede Stater, 600153
- Rekruttering
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Afsluttet
- KUMC
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71103
- Rekruttering
- LSU Health Sciences Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Fall River, Massachusetts, Forenede Stater, 02720
- Rekruttering
- Charlton Memorial Hospital
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Michigan
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Detroit, Michigan, Forenede Stater, 48236
- Rekruttering
- Ascension St. John Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- Afsluttet
- University of Minnesota
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- Rekruttering
- University of Mississippi Medical Center
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- Rekruttering
- Mercy Hospital South
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Rekruttering
- Cooper Health System
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Rekruttering
- Lovelace Health System
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New York
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount Sinai Hospital
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University Medical Center/NYPH
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Bellevue Hospital Center
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Roslyn, New York, Forenede Stater, 11576
- Rekruttering
- St. Francis Hospital and Heart Center
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Staten Island, New York, Forenede Stater, 10305
- Rekruttering
- Staten Island University Hospital
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- SUNY Upstate Medical University
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27607
- Rekruttering
- NC Heart and Vascular Research
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
- Rekruttering
- TriHealth Good Samaritan Hospital
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Cincinnati, Ohio, Forenede Stater, 45219
- Afsluttet
- Christ Hospital
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Columbus, Ohio, Forenede Stater, 43213
- Rekruttering
- Mount Carmel East
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Kettering, Ohio, Forenede Stater, 45429
- Rekruttering
- Kettering Medical Center
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Toledo, Ohio, Forenede Stater, 43606
- Rekruttering
- ProMedica Toledo Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Rekruttering
- INTEGRIS Baptist Medical Center
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Tulsa, Oklahoma, Forenede Stater, 74104
- Rekruttering
- Hillcrest Medical Center
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Pennsylvania
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Harrisburg, Pennsylvania, Forenede Stater, 17101
- Rekruttering
- UPMC Harrisburg
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Rekruttering
- Temple University Hospital
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rekruttering
- Miriam Hospital
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
- Rekruttering
- Jackson-Madison County General Hospital
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Knoxville, Tennessee, Forenede Stater, 37934
- Rekruttering
- Turkey Creek Medical Center
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Texas
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San Antonio, Texas, Forenede Stater, 78112
- Rekruttering
- Methodist Hospital Metropolitan
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The Woodlands, Texas, Forenede Stater, 77385
- Rekruttering
- Houston Methodist The Woodlands Hospital
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Tyler, Texas, Forenede Stater, 75701
- Rekruttering
- Christus Mother Frances Hospital
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Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Rekruttering
- Sentara Norfolk General
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin
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Leiden, Holland, 2333 ZA
- Rekruttering
- Leids Universitair Medisch Centrum
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Grosseto, Italien, 58100
- Rekruttering
- Ospedale Misericordia
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Torino, Italien, 10154
- Rekruttering
- Ospedale San Giovanni Bosco
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Krakow, Polen, 31-202
- Rekruttering
- Krakowski Szpital Specjalistyczny św. Jana Pawła II
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Otwock, Polen, 05-400
- Rekruttering
- Europejskie Centrum Zdrowia Otwock
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Poznan, Polen, 61-848
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, Polen, 02-005
- Rekruttering
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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Carnaxide, Portugal, 2790-134
- Rekruttering
- Hospital de Santa Cruz
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Bern, Schweiz, CH-3010
- Rekruttering
- Inselspital, Universitätsspital Bern
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Granada, Spanien, 18014
- Rekruttering
- Hospital Universitario Virgen de la Nieves
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Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Clínico Universitario Lozano Blesa
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Mainz, Tyskland, 55131
- Rekruttering
- Universitaetsmedizin Mainz
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Weinheim, Tyskland, 69469
- Afsluttet
- GRN-Klinik Weinheim
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Baden-Wurttemberg
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Mannheim, Baden-Wurttemberg, Tyskland, 68167
- Rekruttering
- Universitätsmedizin Mannheim
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Graz, Østrig, 8036
- Rekruttering
- MedUni Graz-Univ.-Klinikum Graz
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with acute pulmonary embolism
Beskrivelse
Inclusion Criteria:
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
- Frontline endovascular treatment with the Indigo Aspiration System per IFU
- Patient is ≥ 18 years of age
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
- Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
- Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 180 days
- Patients on ECMO
- Pregnant patients
- Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
- Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patienter med akut lungeemboli
|
Indigo Aspiration System |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety: Composite of major adverse events
Tidsramme: 48 hours
|
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury |
48 hours
|
|
Performance: Change in RV/LV Ratio
Tidsramme: 48 hours post-procedure
|
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available) |
48 hours post-procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af enhedsrelaterede SAE(r)
Tidsramme: 365 dage
|
365 dage
|
|
|
Dødelighed af enhver årsag
Tidsramme: Inden for 30 dage
|
Inden for 30 dage
|
|
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Symptomatisk PE-gentagelse
Tidsramme: Inden for 30 dage
|
Inden for 30 dage
|
|
|
Quality of Life assessed via PEmb-QoL
Tidsramme: 90 days post-procedure
|
Self-assessment of PE related complaints and daily living limitations (including work and social) |
90 days post-procedure
|
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Quality of Life assessed via EQ-5D-5L
Tidsramme: 90 days post-procedure
|
Self-assessment of activities of daily living |
90 days post-procedure
|
|
Functional outcome assessed NYHA
Tidsramme: 90 days post-procedure
|
Physician assessment of heart failure symptoms and activity level |
90 days post-procedure
|
|
Functional outcome assessed via 6MWT
Tidsramme: 90 days post-procedure
|
Walking distance over a 6 minute period to assess functional capacity |
90 days post-procedure
|
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Perceived dyspnea assessed via Borg Scale
Tidsramme: 90 days post-procedure
|
Category rating scale to measure perceived dyspnea |
90 days post-procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: John Moriarty, MD, University of California, Los Angeles
- Ledende efterforsker: Aleksander Araszkiewicz, MD, PhD, Uniwersytecki Szpital Kliniczny w Poznaniu
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. juni 2021
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. februar 2028
Datoer for studieregistrering
Først indsendt
26. februar 2021
Først indsendt, der opfyldte QC-kriterier
11. marts 2021
Først opslået (Faktiske)
15. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18135
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ja
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Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .