Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies
Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5G1Z6
- University Health Network, Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H3A1A1
- McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Needle Guidance
Lung biopsies performed with the needle guidance system.
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Three different groups of patients defined per lesion size
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 30 to 60 minutes after starting the biopsy procedure
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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
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure
Lasso di tempo: 30 to 60 minutes
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30 to 60 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Paul Narinder, MD, University Health Network, Toronto
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ACST-2010-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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