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Treating Onychomychosis

Primary Purpose

Onychomycosis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Noveon laser
Sponsored by
Nomir Medical Technologies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • positive onychomycosis
  • negative pregnancy

Exclusion Criteria:

  • peripheral neuropathy

Sites / Locations

  • Nomir Medical

Outcomes

Primary Outcome Measures

Complete or near complete disappearance of toenail fungus

Secondary Outcome Measures

Full Information

First Posted
October 18, 2008
Last Updated
October 20, 2008
Sponsor
Nomir Medical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT00776464
Brief Title
Treating Onychomychosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nomir Medical Technologies

4. Oversight

5. Study Description

Brief Summary
A study to treat 4 toes at a time to eliminate Onychomycosis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Noveon laser
Intervention Description
Two wavelenghts of light
Primary Outcome Measure Information:
Title
Complete or near complete disappearance of toenail fungus
Time Frame
360 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older positive onychomycosis negative pregnancy Exclusion Criteria: peripheral neuropathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Robbins, MD
Phone
781-893-1000
Email
alanhrobbins@comcast.com
Facility Information:
Facility Name
Nomir Medical
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02452
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan robbins, MD
Phone
781-893-1000
Email
alanrobbins@comcast.com

12. IPD Sharing Statement

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Treating Onychomychosis

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