iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
NCT ID: NCT05416086
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-09-03
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iCLAS Cryoablation arm
all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month
cryoablation procedure using the iCLAS Cryoablation System
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Interventions
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cryoablation procedure using the iCLAS Cryoablation System
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Eligibility Criteria
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Inclusion Criteria
* Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System
* Subject willing to comply with study requirements and give informed consent.
Exclusion Criteria
* Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor.
* Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)
18 Years
ALL
Yes
Sponsors
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Adagio Medical
INDUSTRY
Responsible Party
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Locations
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Onze-Lieve-Vrouw Hospital Aalst (OLV)
Aalst, , Belgium
Universitatsklinikum Erlangen
Erlangen, , Germany
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Tom de Potter, MD
Role: primary
Lars Anneken, MD
Role: primary
Lucas Boersma, MD
Role: primary
Tamas Szili-Torok, MD
Role: primary
Other Identifiers
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CS-086
Identifier Type: -
Identifier Source: org_study_id
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