Trials / Completed
CompletedNCT04869462
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer
- Kidney Cancer
- Congenital Abnormality of Kidney
- Nephrolithiasis
- Kidney Tuberculosis
- Nephritis
- Kidney Injury
- Hydronephrosis
Timeline
- Start date
- 2021-05-27
- Primary completion
- 2022-01-26
- Completion
- 2022-01-29
- First posted
- 2021-05-03
- Last updated
- 2022-04-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04869462. Inclusion in this directory is not an endorsement.