Trial document




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  DRKS00009220

Trial Description

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Title

Examination of head and neck tissue specimens with optical coherence tomography and narrow band imaging

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Trial Acronym

n/a

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URL of the Trial

http://n/a

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

In the recent years there was a continous development in the imaging techniques for visualiation of head and neck anatomy and pathology. New optical techniques like Optical Coherence Tomography (OCT) and Narrow Band Imaging (NBI) had substantial progress and are now established in certain medcial sectors. Since it was developed in 1991 OCT became a routine part for the examination of the retina (Huang 1991, Massin 2006). With technical modifications it is also possible to use OCT for the examination of the normal anatomy, for example lymphatic drainage. NBI is used for evaluation of mucosal alterations for example in gastroenerology or urology (Boeriu 2015, Casey 2015). During the last years the use of NBI was also evaluated for head and neck disease showing advantages in the diagnosis of laryngeal papillomatosis (Dippold 2015). Possible use for head and neck surgeons are therefore examination of the anatomy and pathological influences (inflammation, neoplasm). The use in the head and neck area was restricted by the size of the probes. The development of more and more smaller probes now enables further examinations. Analysis of picure quality and feasibility are aim of this study.

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Organizational Data

  •   DRKS00009220
  •   2015/08/12
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  •   yes
  •   Approved
  •   294/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Neoplasms and malignancies of the upper airway, the nose, the paranasal sinuses, external ear channel, middle ear and head and neck skin
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Interventions/Observational Groups

  •   Patients with scheduled surgical procedures are choosen. Informed consent is obtained. A small part of the tissue specimen which is resected anyway are examined with different OCT- and NBI-probes. Pictures are analyzed concerning quality. The largest part of the tissue specimen is brought to histopathologic examination.
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Characteristics

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

Same imaging quality with new OCT- and NBI-probes compared to conventional, larger tools

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/11/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Male and female patients and test persons over the age of 18 yrs.

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Exclusion Criteria

Persons under the age of 18 yrs., pregnant women, emergency patients, persons unable to consent, persons suffering from dementia, disabled persons

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universität Freiburg, Institut für Mikrosystemtechnik, Gisela-und-Erwin-Sick-Professur für Mikrooptik
    • Mr.  Prof.  Hans  Zappe 
    • Georges-Köhler-Allee 102
    • 79110  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-HNO-Klinik Freiburg
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.