DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
NCT ID: NCT05543447
Last Updated: 2025-09-04
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
158 participants
OBSERVATIONAL
2022-12-15
2026-12-31
Brief Summary
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Detailed Description
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The study duration is expected to be 36 months of enrolment and 12 months follow-up of patients. Up to 158 patients should be enroled at approx. 15 study sites in Germany.
Informed consent will be obtained from all patients prior to implantation of the DERIVO® 2heal® Embolisation Device. In exceptional cases, informed consent may be obtained after the intervention, as the study is purely data collection. It should be noted that the signed informed consent form must be obtained before recording of data in the study and prior any study-specific assessments. Informed consent process will be performed according to ICH-GCP standards. In case of emergency situations when the treatment needs to be performed immediately and informed consent cannot be given prior to the rescue treatment, the informed consent can be obtained retrospectively from the patient or patient's legal representative.
The analysis population will be consist of all patients enrolled who were treated with DERIVO® 2heal® Embolisation device or in whom an attempt of DERIVO® 2heal® Embolisation device implantation was made.
Personal data will be processed in accordance with the relevant national and international legislation and good clinical practice. Data will only be processed for the purpose of the PMCF study. Person-identifiable data will not leave the unit from which they originated, and for pseudonymized data, keys to identification numbers will be held confidentially by the responsible person. Individual patient's medical information will be recorded in the study only in pseudonymized form.
All data in this project are captured in eCRFs and stored into an electronic clinical database. Quality control and data validation procedures such as programmed automatic edit and consistency checks ensure data validity and accuracy immediately at the point of entry into this database. The database application which is used to capture electronic clinical trial data is protected from unauthorized access it is, among other features, access restricted, contains rights and roles functionalities, provides electronic authentication of data entries, maintains an electronic audit trail and provides appropriate data backup functionalities.
After data entry, study monitoring team will perform source data verification and issue monitoring queries directly in the database application.
The database will only be locked after all queries and discrepancies that may have occurred during data entry have been resolved. After database lock, data will be exported in an electronic format and transferred to the responsible biometrician for analysis. The locked database may also be used to generate subject listings and tabulations.
The results of the trial will be reported to the central Ethics Committees after the study was completed. By signing the protocol, the investigator agrees that the results of the clinical investigation may be used for publication. The investigator also agrees that is not permitted to publish any data related to the trial independent of the Sponsor.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device
Flow diversion therapy fpr intracranial aneurysm treatment.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Signed Informed Consent Form
* Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device
* Effective use of antiplatelet medication confirmed by applicable testing method according to local standard
Exclusion Criteria
* Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient
* Patient with a ruptured aneurysm in the acute phase of bleeding
* Pre-treatment disability (mRS \> 2)
* Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel
* Contraindication against treatment with anti-platelet medication
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
* Participating in another study
18 Years
ALL
No
Sponsors
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Acandis GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Behme Daniel, Prof.
Role: STUDY_DIRECTOR
Universitätsklinikum Magdeburg
Locations
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Universitätsklinikum Augsburg
Augsburg, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Klinikum Bremerhaven-Reinkenheide
Bremerhaven, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Essen
Essen, , Germany
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, , Germany
Universitätsmedizin Halle
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Mühlenkreiskliniken | Johannes Wesling Klinikum Minden
Minden, , Germany
Ludwig-Maximilians-Universität München
München, , Germany
Technische Universität München
München, , Germany
Klinikum Vest - Knappschaftskrankenhaus Recklinghausen
Recklinghausen, , Germany
Städtisches Klinikum Solingen
Solingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Ansgar Berlis, Prof.
Role: primary
George Bohner, Dr.
Role: primary
Timo Phung, Dr.
Role: primary
Christoph Kabbasch, Prof.
Role: primary
Johannes Gerber, Dr.
Role: primary
Cornelius Deuschl, Dr.
Role: primary
Ansgar Schütz, Dr.
Role: primary
Stefan Schob, PD Dr.
Role: primary
Maxim Bester, PD Dr.
Role: primary
Andreas Simgen, Dr.
Role: primary
Christoph Mönninghoff, Prof.
Role: primary
Thomas Liebig, Prof.
Role: primary
Tobias Boeckh-Behrens, Dr.
Role: primary
Christian Loehr, Dr.
Role: primary
Hannes Nordmeyer, Dr.
Role: primary
Other Identifiers
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REheal Version 1.3, 03.06.2025
Identifier Type: -
Identifier Source: org_study_id
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