Prostate Cancer Clinical Trial
— DOSTILCUOfficial title:
Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
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 |
Verified date | April 2022 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Ortenau Klinikum Klinik für Urologie und Kinderurologie | Offenburg |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG |
Germany,
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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