Portable Ultrasound for Interventional Procedures
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Portable ultrasound-guided procedures, including paracentesis, thoracentesis, drain placement, or simple biopsies can be required for patients who are difficult to move, in particular COVID-19 patients, patients in the ICU, or on the floor. Portable ultrasounds have demonstrated a convenient ability to provide a point of care ultrasound diagnostic testing with expanding use in standard clinical care. A number of portable ultrasound systems are in routine clinical use at MGH and have been used for diagnostic procedures (e.g. Butterfly, Hologic, others). Most of the systems are still tethered (transducer is connected via cables to a computer or power) which may represent challenges for contamination, especially in interventional procedures. The Healcerion system is the first FDA approved wireless and battery-operated portable ultrasound system of its kind and is in routine use for diagnostic ultrasounds throughout the world.
The goal of the current study is to compare the utility and practical operations of the advanced Healcerion SONON ultrasound system to a standard wheeled and bulky ultrasound systems in current use (Hitachi, GE). While the Healcerion device has been used at other institutions, it has not been used for interventional procedures at MGH. A comparative efficacy study will allow the investigators to examine the safety and efficacy of the device to complete procedures in a portable setting as well as explore whether images can be improved to reach the more robust imaging capability of wired devices.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Avik Som, MD
- Numéro de téléphone: +1-832-330-7557
- E-mail: Avik.Som@MGH.HARVARD.EDU
Sauvegarde des contacts de l'étude
- Nom: Hyungsoon Im, PhD
- Numéro de téléphone: +1-617-643-5679
- E-mail: im.hyungsoon@mgh.harvard.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- The subject has read, signed, and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
- Age ≥ 18 years at the date of informed consent form signature and having the ability to comply with the protocol.
- Undergoing a clinically indicated ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy.
Exclusion Criteria:
- Patient or health care proxy does not consent
- Patient not undergoing an ultrasound-guided procedure.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Adult patients undergoing an ultrasound-guided procedure
Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy
|
Single-arm, open-label device efficacy study to enroll 200 patients who have been ordered to have an ultrasound-guided procedure by the MGH Interventional Radiology department, including paracentesis, thoracentesis, biopsy, or ultrasound-guided drain placement.
Patients will be restricted to adults who can consent.
The FDA approved Healcerion SONON portable ultrasound (linear and curved) will be used during clinically indicated standard ultrasound-guided procedures following clinical standard of care.
A standard clinical ultrasound will subsequently be used for image guidance as the gold standard.
Images will be compared and improved.
The efficacy of the portable ultrasound will be monitored by the clinical user and any complications within 30 days will be determined by chart review.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Efficacy > 80%
Délai: Approximately 3 years
|
Efficacy as defined by the operator in successfully completing the procedure using the portable ultrasound.
Reported % of cases the portable ultrasound successfully completed the procedure, stratified by procedure type.
|
Approximately 3 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2020P003984
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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