DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Prostate Cancer Clinical Trial

— DOSTILCU  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869462
• Other study ID #: AAG-O-H-2041
• Status: Completed
• Start date: May 27, 2021
• Est. completion date: January 29, 2022

Study information

• Verified date: April 2022
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 29, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hydronephrosis
• Kidney Calculi
• Kidney Cancer
• Kidney Injury
• Kidney Neoplasms
• Nephritis
• Nephrolithiasis
• Prostate Cancer
• Tuberculosis

Locations

Country	Name	City	State
Germany	Ortenau Klinikum Klinik für Urologie und Kinderurologie	Offenburg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative blood loss	Estimated intraoperative blood loss	intraoperatively
Other	Total operative time	Estimated operative time from first cut to last stitch	intraoperatively
Other	Length of hospital stay	Length of patient's stay in hospital after surgery	up to discharge from hospital (approximately 10 days post surgery)
Other	Handling parameters	The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects	intraoperatively
Primary	Rate of slippage / movement of the clip in relationship to the total number of used clips.	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.	Intraoperatively
Secondary	Rate of Adverse events (intra- and postoperative)	Postoperative bleedings; Infections; Urine extravasation in partial nephrectomy; Prolonged urinary catheter drainage in radical prostatectomies; Ileus; Venous thrombo-embolic events; Sepsis; Other	up to discharge from hospital (approximately 10 days post surgery)