Clinical trial · Observational
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)
NCT04869462CI-TRIAL-00057729DOSTILCUcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Abnormality of Kidney | — | UNRESOLVED | — |
| Hydronephrosis | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Injury | — | UNRESOLVED | — |
| Kidney Tuberculosis | — | UNRESOLVED | — |
| Nephritis | — | UNRESOLVED | — |
| Nephrolithiasis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of slippage / movement of the clip in relationship to the total number of used clips.
- timeFrame
- Intraoperatively
- description
- 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.
Secondary outcomes (1)
- measure
- Rate of Adverse events (intra- and postoperative)
- timeFrame
- up to discharge from hospital (approximately 10 days post surgery)
- description
- * Postoperative bleedings * Infections * Urine extravasation in partial nephrectomy * Prolonged urinary catheter drainage in radical prostatectomies * Ileus * Venous thrombo-embolic events * Sepsis * Other
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.