Clinical trial NCT04869462: DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Official title: Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Kidney Cancer
Congenital Abnormality of Kidney
Nephrolithiasis
Kidney Tuberculosis
Nephritis
Kidney Injury
Hydronephrosis
Keywords: Ligature of vessels and hollow organs
Marking of anatomic structures for radiological detection
Ligation
Prostatectomy
Nephrectomy
Minimally Invasive Surgical Procedures
Laparoscopy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.

Brief summary: 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: 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.

Eligibility criteria: Inclusion: 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: Exclusion Criteria:

• None

Primary outcomes:
measure: Rate of slippage / movement of the clip in relationship to the total number of used clips.
timeFrame: Intraoperatively
Secondary outcomes:
measure: Rate of Adverse events (intra- and postoperative)
timeFrame: up to discharge from hospital (approximately 10 days post surgery)
Other outcomes:
measure: intraoperative blood loss
timeFrame: intraoperatively
measure: Total operative time
timeFrame: intraoperatively
measure: Length of hospital stay
timeFrame: up to discharge from hospital (approximately 10 days post surgery)
measure: Handling parameters
timeFrame: intraoperatively
Locations:
city: Offenburg
country: Germany
facility: Ortenau Klinikum Klinik für Urologie und Kinderurologie
Study officials:
affiliation: Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg
name: Jörg Simon, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: