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
  Purpose

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.


Condition Intervention Phase
Cutaneous Neurofibromas
Procedure: Erbium-YAG laser vaporization
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: April 2006
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921037

Contacts
Contact: Wolfgang Happak, Prof. MD 0043-1-40400 ext 6980 lukikriechbaumer@hotmail.com
Contact: Lukas Kriechbaumer, MD 0043-650-8423766 lukasKriechbaumer@meduniwien.ac.at

Locations
Austria
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    lukikriechbaumer@hotmail.com   
Principal Investigator: Wolfgang Happak, Prof. MD         
Sub-Investigator: Lukas Kriechbaumer, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Wolfgang Happak, Prof. MD Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
  More Information

Publications:
Responsible Party: Wolfgang Happak, Prof. MD, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
ClinicalTrials.gov Identifier: NCT00921037     History of Changes
Other Study ID Numbers: EK Nr: 128/2006
Study First Received: June 15, 2009
Last Updated: July 11, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Neurofibromatosis Type 1
Morbus Recklinghausen
cutaneous neurofibromas
Erbium-YAG-Laser
Vaporisation
Thermal Necrosis

Additional relevant MeSH terms:
Neurofibroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014