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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)
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of slippage / movement of the clip in relationship to the total number of used clips. | Slippage / movement of the Aesculap® DS Titanium Ligation Clip is an observable slippage, movement, or rotation after the clip was successfully applied and the application forceps was removed. The number of observed slippage / movement of the clip will be documented on the CRF, the clip size, step of the procedure and further measures were necessary, i.e. removal of the clip or application of another clip, will be documented. In the end the rate will be brought in relationship to the overall number of applied clips. Thus, the number of applied clips is documented, for each clip size. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse events (intra- and postoperative) |
| up to discharge from hospital (approximately 10 days post surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative blood loss | Estimated intraoperative blood loss | intraoperatively |
| Total operative time | Estimated operative time from first cut to last stitch |
Inclusion: Inclusion Criteria:
Exclusion: Exclusion Criteria:
• None
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Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Simon, PD Dr. med. | Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ortenau Klinikum Klinik für Urologie und Kinderurologie | Offenburg | 77654 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007680 | Kidney Neoplasms |
| D053040 | Nephrolithiasis |
| D014398 | Tuberculosis, Renal |
| D009393 | Nephritis |
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| intraoperatively |
| Length of hospital stay | Length of patient's stay in hospital after surgery | up to discharge from hospital (approximately 10 days post surgery) |
| Handling parameters | The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects | intraoperatively |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052878 | Urolithiasis |
| D014401 | Tuberculosis, Urogenital |
| D000092225 | Tuberculosis, Extrapulmonary |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |