DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Completed

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

• Registration Number: NCT04869462
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-03
• Study Start: 2021-05-27
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of slippage / movement of the clip in relationship to the total number of used clips.	Intraoperatively	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 Outcome Measures

Name	Time	Method
Rate of Adverse events (intra- and postoperative)	up to discharge from hospital (approximately 10 days post surgery)	* Postoperative bleedings; * Infections; * Urine extravasation in partial nephrectomy; * Prolonged urinary catheter drainage in radical prostatectomies; * Ileus; * Venous thrombo-embolic events; * Sepsis; * Other

Trial Locations

Locations (1)

Ortenau Klinikum Klinik für Urologie und Kinderurologie; 🇩🇪 Offenburg, Germany