An observational study in Prostate Cancer, Kidney Cancer and Congenital Abnormality of Kidney, sponsored by Aesculap AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 67 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.
Inclusion: Inclusion Criteria:
Exclusion: Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Intraoperatively
Rate of Adverse events (intra- and postoperative)
* Postoperative bleedings * Infections * Urine extravasation in partial nephrectomy * Prolonged urinary catheter drainage in radical prostatectomies * Ileus * Venous thrombo-embolic events * Sepsis * Other
Time frame: up to discharge from hospital (approximately 10 days post surgery)
intraoperative blood loss
Estimated intraoperative blood loss
Time frame: intraoperatively
Total operative time
Estimated operative time from first cut to last stitch
Time frame: intraoperatively
Length of hospital stay
Length of patient's stay in hospital after surgery
Time frame: 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
Time frame: intraoperatively
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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