First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas
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|ClinicalTrials.gov Identifier: NCT00921037|
Recruitment Status : Unknown
Verified June 2009 by Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : June 16, 2009
Last Update Posted : July 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Neurofibromas||Procedure: Erbium-YAG laser vaporization||Phase 2 Phase 3|
With a prevalence of 1 in 3-5000 births, neurofibromatosis Type I is one of the most common genetic defects. The mode of inheritance is autosomal dominant and affects a gene (NF1), which is responsible for the production of the tumor suppressor protein neurofibromin. The consequence is an uninhibited expansion of neural tissue which leads amongst others to cosmetic disfigurement of the patients. In comparison to the plexiform neurofibromas the cutaneous tumors do not undergo malignant transformation.
Excision and CO2 laser vaporisation were established as standard treatment but cause unattractive scars.
In one operation more than 500 neurofibromas can be removed with an Erbium: YAG laser (2940 nm). The tumors are dissected by shooting holes into the skin and vaporising the neurofibromas in-between or underneath. Specimen are harvested after Er: YAG-, CO2 - and electrosurgical treatment to evaluate the difference of thermal necrosis histologically and photographs are taken to assess the cosmetic results.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||November 2012|
Experimental: Erbium YAG Laser
Patients with Neurofibromatosis Type 1 (Recklinghausen)
Procedure: Erbium-YAG laser vaporization
spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz
- The aim of this study is to enhance the quality of life (measured by the Nottingham Health Profile the Rosenberg's Self-Esteem Scale and the SF-36 health survey) of patients suffering from disfigurement due to thousands of cutaneous neurofibromas. [ Time Frame: 6 months ]The standardized questionnaires are done before and 6 month after the operation in which the tight tumor cluster are phased down and thereby an almost normal skin appearance is achieved.
- With this new method we want to decrease the painfulness, accelerated the time till wound healing as well as reduce the stay in hospital and the incidence of side effects. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921037
|Contact: Wolfgang Happak, Prof. MD||0043-1-40400 ext firstname.lastname@example.org|
|Contact: Lukas Kriechbaumer, MD||0043-650-8423766||lukasKriechbaumer@meduniwien.ac.at|
|Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Wolfgang Happak, Prof. MD 0043-1-40400 ext 6980 email@example.com|
|Principal Investigator: Wolfgang Happak, Prof. MD|
|Sub-Investigator: Lukas Kriechbaumer, MD|
|Principal Investigator:||Wolfgang Happak, Prof. MD||Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria|