Trial document




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  DRKS00005053

Trial Description

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Title

Pilot study for flexible edoscopic examination and endoluminal occlusion of the saminal duct

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Trial Acronym

FlexEndo-SemDuct

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The presented research aims the development of an optical system, which allows an endoscopic inspection of the entire seminal duct (ejaculatory duct, vas deferens and seminal vesica). In the first phase, the construction of a proper flexible optics attached to a high-resolution visualization system is targeted. So far, the inspection of the seminal tract was limited by the use of rigid instruments (mostly thin ureterorenoscopes). With regard to the recent technical progress of the optical technologies there are real chances to build such instruments.
Currently there are small-sized, flexible optical system for industrial applications on the market. Those instruments are narrow enough to be potentially able to inspect the entire seminal tract.
The aim of the research project is to develop and optimize such endoscopes for human use. For this purpose the first step is to create and describe the technical and physical properties of such systems. The second step are cadaver studies on the human seminal duct (University of Giessen, Department of Urology & Anatomy Institute). In addition we investigate how the optics can be applied in terms of endoluminal occlusion of the seminal duct for fertility control.
Here different materials are inserted to the vas deferens (porcine model) to occlude their lumen. Subsequently, the density of the different materials is tested and evaluated in the lab. Finally, we investigate a CE approved, small-sized optical system for its applicability to endoscopically examine the human seminal duct.

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Brief Summary in Scientific Language

Four-stage analysis on the medical applicability of a new, miniaturized, flexible optical system for endoscopy of the seminal tract.
Step 1: investigation and physical characterization of the optics
Step 2: Test on human cadaver
Step 3: Investigation whether the new optics are suitable for optical control of endoluminal occlusion of the seminal duct for fertility control (lab study on a porcine genital tract model).
Step 4: Clinical test of a CE approved small-sized flexible endoscopy system on male patients with hematospermia and/or as a part of transurethral resection of the prostate.

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Organizational Data

  •   DRKS00005053
  •   2015/03/13
  •   [---]*
  •   yes
  •   Approved
  •   296/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   N50.1 -  Vascular disorders of male genital organs
  •   N50.8 -  Other specified disorders of male genital organs
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Interventions/Observational Groups

  •   not applicable for steps 1,2,3 (step 1 - physical specification of a flexible microoptical system for endoscopic inspection of the human seminal tract, step 2 - test on human cadaver, step 3 - laboratory investigation of endoluminal inspection of ductus deferens in porcine model)
    step 4: clinical tests on patients with hematosperia and/or as a part of transurethral resektion of the prostate (during this procedure certain structures of the male seminal duct are damaged irreversibelly)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Feasibility of microoptical, flexible endoscopy of the male seminal duct in human cadaver model and in patients

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Secondary Outcome

clinical side effects after microoptical inspection of the human seminal duct

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/05/18
  •   10
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Hematospermia, BPS

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Exclusion Criteria

Women, absence of consent, history of surgical interventions on genital tract

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Addresses

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    • Uniklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
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    • Uniklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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