DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

NCT ID: NCT04869462

Last Updated: 2022-04-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-01-29

Brief Summary

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Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Detailed Description

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The objective of this observational study is to collect systematically and proactively data regarding the Aesculap® DS Titanium Ligation Clip under daily clinical practice when used in urology in different indications.

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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Prostate Cancer Kidney Cancer Congenital Abnormality of Kidney Nephrolithiasis Kidney Tuberculosis Nephritis Kidney Injury Hydronephrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Planned Da Vinci radical prostatectomy using DS Titanium Ligation Clips (according to the IfU) - OR
* 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

• None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2041

Identifier Type: -

Identifier Source: org_study_id

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