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Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies

20. december 2012 opdateret af: ActiViews Ltd.

Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System

This study is designed to provide clinical data regarding safety and clinical effectiveness of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous needle biopsy or aspiration of pulmonary lesions, which is a common procedure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This will be a prospective, single-arm study. At least three centers in Canada will participate in the study and at least 4 different experienced staff radiologists will perform the procedures for the study.

A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled for clinically indicated CT guided lung biopsy or aspiration procedure at the participating centers will be invited to enroll in the study. To ensure diversity in the study population, consecutive patients will be enrolled in the following groups until these groups are fully enrolled:

Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size >1.5 and ≤ 3.0 cm: 19 patients; Lesion size >3.0 cm: 19 patients.

A maximum of 24 patients will be enrolled at each center.

Informed consent will be signed prior to the procedure. Subject data collection on the day of the procedure will include demographics, relevant medical history and vital signs. Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance System. Subjects will be followed-up as outlined below to assess adverse events related to the procedure. A subject's enrollment in the study will be completed after the follow-up visit or after resolution of any procedure related adverse event.

A procedure difficulty classification is defined for this study, based on existing literature. Difficulty levels for all procedures will be recorded and included in the final report.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G1Z6
        • University Health Network, Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital

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

14 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older at the time of enrollment;
  • Subjects scheduled for clinically indicated CT guided percutaneous lung aspiration/biopsy;
  • Written informed consent to participate in the study;
  • Ability to comply with the requirements of the study procedures;
  • Verified home address and phone number to facilitate study follow-up.

Exclusion Criteria:

  • Significant coagulopathy that cannot be adequately corrected;
  • Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment;
  • Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study;
  • Subjects who are uncooperative or cannot follow instructions;
  • Mental impairment that may preclude completion of the study procedure;
  • Pregnant or nursing female subjects.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Needle Guidance
Lung biopsies performed with the needle guidance system.
Enhed: ActiSight Needle Guidance System
Three different groups of patients defined per lesion size
Andre navne:
  • CT-Guide Needle Guidance System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients with successful targeting accuracy as defined by the frequency of placing the needle at a location suitable for obtaining tissue sample from the target lesion.
Tidsramme: 30 to 60 minutes after starting the biopsy procedure

Needle location suitable for obtaining tissue sample will be determined by a physician reviewing the CT images.

All 48 subjects undergoing aspiration or biopsy procedures with the CT met the primary efficacy endpoint of placement of the procedure needle at a location suitable for obtaining a tissue sample from the target lesion as determined by the investigator (100%; 95% CI, 93-100%).
30 to 60 minutes after starting the biopsy procedure

Sekundære resultatmål

Resultatmål
Tidsramme
Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure
Tidsramme: 30 to 60 minutes
30 to 60 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ActiViews Ltd.

Efterforskere

  • Ledende efterforsker: Paul Narinder, MD, University Health Network, Toronto

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

1. august 2010

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

13. august 2010

Først indsendt, der opfyldte QC-kriterier

16. august 2010

Først opslået (Skøn)

17. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. december 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2012

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACST-2010-1

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 .

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Placeringer

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