First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00921037
First received: June 15, 2009
Last updated: July 11, 2011
Last verified: June 2009

June 15, 2009
July 11, 2011
April 2006
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
The aim of this study is to enhance the quality of life of patients suffering from disfigurement due to thousands of cutaneous neurofibromas by phasing down the tight tumor cluster and thereby achieving an almost normal skin appearance. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00921037 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas
First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas

The purpose of this study is to determine whether multiple cutaneous neurofibromas in patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous Neurofibromas
Procedure: Erbium-YAG laser vaporization
spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz
Experimental: Erbium YAG Laser
Patients with Neurofibromatosis Type 1 (Recklinghausen)
Intervention: Procedure: Erbium-YAG laser vaporization

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
November 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with multiple cutaneous neurofibromas with the request for tumor removal

Exclusion Criteria:

  • Pregnancy
Both
Not Provided
No
Contact: Wolfgang Happak, Prof. MD 0043-1-40400 ext 6980 lukikriechbaumer@hotmail.com
Contact: Lukas Kriechbaumer, MD 0043-650-8423766 lukasKriechbaumer@meduniwien.ac.at
Austria
 
NCT00921037
EK Nr: 128/2006
No
Wolfgang Happak, Prof. MD, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
Medical University of Vienna
Not Provided
Principal Investigator: Wolfgang Happak, Prof. MD Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
Medical University of Vienna
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP