DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy) (DOSTILCU)

Aesculap

Status: Completed

Conditions: Hydronephrosis; Kidney Tuberculosis; Kidney Cancer; Congenital Abnormality of Kidney; Kidney Injury; Nephritis; Nephrolithiasis; Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04869462

AAG-O-H-2041

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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