DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
NCT ID: NCT04869462
Last Updated: 2022-04-12
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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COMPLETED
67 participants
OBSERVATIONAL
2021-05-27
2022-01-29
Brief Summary
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Detailed Description
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The hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the Instructions for Use (IfU). The observed rate through the total number of clips might be a valuable parameter and could influence future research.
Furthermore, this study is one of the PMCF measures which enable the manufacturer to monitor the safety and performance of the Aesculap® DS Titanium Ligation Clips. The products bear the CE-marking and are routinely used within this institution for the above-mentioned procedures.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Planned laparoscopic nephrectomy using Titanium Ligation Clip (according to the IfU) - OR
* Planned Da Vinci partial nephrectomy using Titanium Ligation Clip (according to the IfU)
* Patient's written informed consent
* Age ≥ 18 years
* Intraoperative Usage of DS Titanium Ligation Clips (according to the IfU)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg Simon, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg
Locations
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Ortenau Klinikum Klinik für Urologie und Kinderurologie
Offenburg, , Germany
Countries
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Other Identifiers
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AAG-O-H-2041
Identifier Type: -
Identifier Source: org_study_id
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