NCT04869462

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 27, 2021

Last Update Submit

April 11, 2022

Conditions

Prostate CancerKidney CancerCongenital Abnormality of KidneyNephrolithiasisKidney TuberculosisNephritisKidney InjuryHydronephrosis

Keywords

Ligature of vessels and hollow organsMarking of anatomic structures for radiological detectionLigationProstatectomyNephrectomyMinimally Invasive Surgical ProceduresLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of Adverse events (intra- and postoperative)

    up to discharge from hospital (approximately 10 days post surgery)

Other Outcomes (4)

  • intraoperative blood loss

    intraoperatively

  • Total operative time

    intraoperatively

  • Length of hospital stay

    up to discharge from hospital (approximately 10 days post surgery)

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data is collected preoperatively, intraoperatively and until discharge of all consecutive patients fulfilling the inclusion and exclusion criteria in a single site.

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortenau Klinikum Klinik für Urologie und Kinderurologie

Offenburg, 77654, Germany

Location

MeSH Terms

Conditions

Prostatic NeoplasmsKidney NeoplasmsNephrolithiasisTuberculosis, RenalNephritisHydronephrosis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesUrolithiasisTuberculosis, UrogenitalTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Jörg Simon, PD Dr. med.

    Ortenau KlinikumKlinik für Urologie und Kinderurologie ChefarztEbertplatz 1277654 Offenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 3, 2021

Study Start

May 27, 2021

Primary Completion

January 26, 2022

Study Completion

January 29, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

DE(1)