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

Primary Purpose

Cutaneous Neurofibromas

Status
Unknown status
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Erbium-YAG laser vaporization
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Neurofibromas focused on measuring Neurofibromatosis Type 1, Morbus Recklinghausen, cutaneous neurofibromas, Erbium-YAG-Laser, Vaporisation, Thermal Necrosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Sites / Locations

  • Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erbium YAG Laser

Arm Description

Patients with Neurofibromatosis Type 1 (Recklinghausen)

Outcomes

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.
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.

Full Information

First Posted
June 15, 2009
Last Updated
July 11, 2011
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00921037
Brief Title
First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas
Official Title
First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Neurofibromas
Keywords
Neurofibromatosis Type 1, Morbus Recklinghausen, cutaneous neurofibromas, Erbium-YAG-Laser, Vaporisation, Thermal Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erbium YAG Laser
Arm Type
Experimental
Arm Description
Patients with Neurofibromatosis Type 1 (Recklinghausen)
Intervention Type
Procedure
Intervention Name(s)
Erbium-YAG laser vaporization
Intervention Description
spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with multiple cutaneous neurofibromas with the request for tumor removal Exclusion Criteria: Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Happak, Prof. MD
Phone
0043-1-40400
Ext
6980
Email
lukikriechbaumer@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas Kriechbaumer, MD
Phone
0043-650-8423766
Email
lukasKriechbaumer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof. MD
Organizational Affiliation
Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof. MD
Phone
0043-1-40400
Ext
6980
Email
lukikriechbaumer@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof. MD
First Name & Middle Initial & Last Name & Degree
Lukas Kriechbaumer, MD

12. IPD Sharing Statement

Citations:
Citation
Algermissen B, Müller U, Katalinic D, Berlien HP. Laserbehandlung von kutanen Neurofibromen. journalmed. 12; 2001.
Results Reference
background
PubMed Identifier
1909107
Citation
Becker DW Jr. Use of the carbon dioxide laser in treating multiple cutaneous neurofibromas. Ann Plast Surg. 1991 Jun;26(6):582-6. doi: 10.1097/00000637-199106000-00016.
Results Reference
background
Citation
Kardorff B. Neurofibromatose Typ I (Morbus Recklinghausen): Kombinierte Erbium.Yag-Laser- und Exzisionstherapie von kutanen Neurofibromen. Derm 1998; 4:404-406
Results Reference
background
PubMed Identifier
11359412
Citation
Moreno JC, Mathoret C, Lantieri L, Zeller J, Revuz J, Wolkenstein P. Carbon dioxide laser for removal of multiple cutaneous neurofibromas. Br J Dermatol. 2001 May;144(5):1096-8. doi: 10.1046/j.1365-2133.2001.04214.x. No abstract available.
Results Reference
background
PubMed Identifier
11896787
Citation
Ostertag JU, Theunissen CC, Neumann HA. Hypertrophic scars after therapy with CO2 laser for treatment of multiple cutaneous neurofibromas. Dermatol Surg. 2002 Mar;28(3):296-8. doi: 10.1046/j.1524-4725.2002.01145.x.
Results Reference
background
PubMed Identifier
11109606
Citation
Querings K, Fuchs D, Kung EE, Hafner J. [CO2-laser therapy of stigmatizing cutaneous lesions in tuberous sclerosis (Bourneville-Pringle) and in neurofibromatosis 1 (von Recklinghausen)]. Schweiz Med Wochenschr. 2000 Nov 11;130(45):1738-43. German.
Results Reference
background
PubMed Identifier
3100595
Citation
Roenigk RK, Ratz JL. CO2 laser treatment of cutaneous neurofibromas. J Dermatol Surg Oncol. 1987 Feb;13(2):187-90. doi: 10.1111/j.1524-4725.1987.tb00517.x.
Results Reference
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First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas

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