Trial document




drksid header

  DRKS00018800

Trial Description

start of 1:1-Block title

Title

Influence of Pulsed Electromagnetic Fields (PEMF) on Microcirculation of the Lymph

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Intraoperative Flow Measurement Using Indocyanine Green (ICG) Fluorescence to Evaluate Influence of PEMF on lymphatic flow in patients with lymphedema during the procedure of lymphovenous anastomoses in a prospective study.
Using fluorescence microscopy during the application of PEMF, the lymph flow can be measured. This is done by means of intraoperative ICG fluorescence in the
Operating microscope, which allows a flow measurement. No additional invasive measures are used. The Measurement takes 1 minute 30 seconds. The effectiveness of PEMF-mediated lymphoma induction is compared to intraoperative intraindividual manual lymphatic drainage. This one will following the PEMF application for 1 minute 30 seconds.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of the study is to investigate the influence of physical vascular therapy by Pulsed Electromagnetic Fields (PEMF) on the microcirculation of lymphatic fluid in patients with lymphedema. This is done during the initiation of lymphovenous shunts. These operations are in independant to our study. Flourescence microscopy is used for analyses.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00018800
  •   2019/10/02
  •   [---]*
  •   yes
  •   Approved
  •   19-1461-101, Ethikkommission an der Universität Regensburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I89.0 -  Lymphoedema, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intraoperative Flow Measurement Using Indocyanine Green (ICG) Fluorescence to Evaluate Influence of PEMF on lymphatic flow in lymphedema during the procedure of lymphovenous anastomoses.
    This is done by means of intraoperative ICG fluorescence in the Operating microscope, which allows a flow measurement. The effectiveness of PEMF-mediated flow stimulation is compared to intraoperative intraindividual manual lymphatic drainage. This one will following the PEMF application for 1 minute 30 seconds.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Measurement of the flow velocity of the lymph during operation of lympgovenous shunt. Measurement is done using "flow 800", a software integrated into the operating microscope.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Comparison to conventional manual lymphatic drainage

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/11/15
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Subjects: patients suffering from primary and secondary lymphoedema, Minimum age = 18 years, gender and body mass index play no part in the selection

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age under 18

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinikum Regensburg
    • Mr.  PD Dr  Christian  Taeger 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Uniklinikum Regensburg
    • Mr.  PD Dr  Christian  Taeger 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik Regensburg
    • Mr.  Dr  Niklas  Biermann 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Uniklinik Regensburg
    • Mr.  PD Dr  Christian  Taeger 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.