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

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT04869462

Collaborator

(none)

Enrollment

Location

8.1

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Kidney Cancer Congenital Abnormality of Kidney Nephrolithiasis Kidney Tuberculosis Nephritis Kidney Injury Hydronephrosis

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 Design

Study Type:

Observational

Actual Enrollment :

67 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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)

Actual Study Start Date :

May 27, 2021

Actual Primary Completion Date :

Jan 26, 2022

Actual Study Completion Date :

Jan 29, 2022

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

intraoperative blood loss [intraoperatively]
Estimated intraoperative blood loss
Total operative time [intraoperatively]
Estimated operative time from first cut to last stitch
Length of hospital stay [up to discharge from hospital (approximately 10 days post surgery)]
Length of patient's stay in hospital after surgery
Handling parameters [intraoperatively]
The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)