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Completed

NCT Number: NCT04869462

DS 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)

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Key information

Conditions

Prostate Cancer Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Congenital Abnormality of Kidney Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gram-Positive Bacterial Infections Hydronephrosis Infections Kidney Cancer Kidney Diseases Kidney Injury Kidney Neoplasms Kidney Tuberculosis Male Urogenital Diseases Mycobacterium Infections Neoplasms Neoplasms by Site Nephritis Nephrolithiasis Prostatic Diseases Prostatic Neoplasms Tuberculosis Tuberculosis, Extrapulmonary Tuberculosis, Renal Tuberculosis, Urogenital Urogenital Diseases Urogenital Neoplasms Urolithiasis Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ortenau Klinikum Klinik für Urologie und Kinderurologie

Offenburg, 77654, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of Adverse events (intra- and postoperative)

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

    • Postoperative bleedings
    • Infections
    • Urine extravasation in partial nephrectomy
    • Prolonged urinary catheter drainage in radical prostatectomies
    • Ileus
    • Venous thrombo-embolic events
    • Sepsis
    • Other

Other outcomes

  1. intraoperative blood loss

    Time frame: intraoperatively

    Estimated intraoperative blood loss

  2. Total operative time

    Time frame: intraoperatively

    Estimated operative time from first cut to last stitch

  3. Length of hospital stay

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

    Length of patient's stay in hospital after surgery

  4. Handling parameters

    Time frame: intraoperatively

    The handling performance of the clip is assessed on a five point likert scale (very good, good, acceptable, poor) in four different handling aspects

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

Acronym: DOSTILCU

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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