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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04869462
Other study ID # AAG-O-H-2041
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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