Prostate CancerDOSTILCUNCT04869462
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
An observational study of Prostate Cancer and Kidney Cancer, run by Aesculap AG at 1 site in Germany.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Kidney Cancer, Congenital Abnormality of Kidney
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2021to 29 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ortenau Klinikum Klinik für Urologie und Kinderurologie
Offenburg, 77654
About this study
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)
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Read the 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.
- Conditions
- Prostate Cancer, Kidney Cancer, Congenital Abnormality of Kidney, Nephrolithiasis, Kidney Tuberculosis, Nephritis
- Keywords
- Ligature of vessels and hollow organs, Marking of anatomic structures for radiological detection, Ligation, Prostatectomy, Nephrectomy, Minimally Invasive Surgical Procedures, Laparoscopy
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms, Nephrolithiasis, Tuberculosis, Renal, Nephritis, Hydronephrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
Secondary outcomes (1)
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
Measured: up to discharge from hospital (approximately 10 days post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start27 May 2021
- Primary completion26 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Simon, PD Dr. med., Principal investigator, Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869462
- Sponsor's protocol ID
- AAG-O-H-2041
- Acronym
- DOSTILCU
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04869462
- Acronym / sponsor ID
- DOSTILCU / AAG-O-H-2041
- Conditions
- Prostate Cancer, Kidney Cancer, Congenital Abnormality of Kidney, Nephrolithiasis, Kidney Tuberculosis, Nephritis
- Keywords
- Ligature of vessels and hollow organs, Marking of anatomic structures for radiological detection, Ligation, Prostatectomy, Nephrectomy, Minimally Invasive Surgical Procedures, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of slippage / movement of the clip in relationship to the total number of used clips.
Time frame: 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.
1 secondary outcome
Rate of Adverse events (intra- and postoperative)
Time frame: up to discharge from hospital (approximately 10 days post surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Simon, PD Dr. med. principal investigator
Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Kidney Cancer, run by Aesculap AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of slippage / movement of the clip in relationship to the total number of used clips. (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.