Une étude des cisailles HARMONIC 700 avec hémostase avancée dans les procédures chirurgicales pédiatriques et adultes
Une étude prospective multicentrique à un seul bras des cisailles HARMONIC ™ 700, de 5 mm de diamètre avec hémostase avancée dans les procédures chirurgicales pédiatriques (générales) et les procédures chirurgicales chez l'adulte (générales, gynécologiques, urologiques et thoraciques)
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Centre Hospitalier de l'Universite de Montreal
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Dorchester, Royaume-Uni, DT1 2JY
- Dorset County Hospital Nhs Foundation Trust
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Edinburgh, Royaume-Uni, EH4 2XU
- Western General Hospital
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Southampton, Royaume-Uni, SO16 6YD
- Southampton General Hospital
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Yeovil, Royaume-Uni, BA214AT
- Yeovil District Hospital
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Riley Hospital for Children at Indiana University Health
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New York
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New York, New York, États-Unis, 10029
- Icahn School of Medicine at Mt. Sinai
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).
La description
Inclusion Criteria:
Pediatric participants
- Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
- Less than 18 years of age at the time of procedure
- Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
Exclusion Criteria:
Preoperative
- Physical or psychological condition which would impair study participation
- Participants of childbearing potential who are pregnant
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
- HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears)
This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery. |
There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Délai: Intraoperative
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Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example [e.g.], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures. |
Intraoperative
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Number of Participants with Device-Related Adverse Events (AEs)
Délai: Up to approximately 1 year and 7 months
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An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. |
Up to approximately 1 year and 7 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm)
Délai: Intraoperative
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Number of vessel transections with achievement of Grade 3 or lower hemostasis for each vessel transection of diameter > 5 to 7 mm will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures. |
Intraoperative
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ethicon Endo-Surgery, Inc. Clinical Trial, Ethicon Endo-Surgery, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- ENG202301
- ENG202301 (Autre identifiant: Ethicon Endo-Surgery)
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
produit fabriqué et exporté des États-Unis.
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