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Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00948519
Recruitment Status : Unknown
Verified July 2009 by New York Head & Neck Institute.
Recruitment status was:  Recruiting
First Posted : July 29, 2009
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
Valam Corp.
Information provided by:
New York Head & Neck Institute

Tracking Information
First Submitted Date  ICMJE July 28, 2009
First Posted Date  ICMJE July 29, 2009
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
Quality of Life improvement with disease control. Disease control without antibiotics or steroids. [ Time Frame: 1-2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
Laser safety without compromising disease progress [ Time Frame: immediate and late ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
Official Title  ICMJE Laser Microbial Killing With Photo Activated Agents
Brief Summary

Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication. The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery (FESS).

As the disease course is generally idle, prolonged medical treatment guidelines are for antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures, lasting weeks with or without additional topical or oral steroid treatment. While FESS success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than medical management.

With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS are Coagulase-negative staphylococci were the most common isolates (36%), followed by Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and anaerobes (6.4%).

Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus and Pseudomonas aeruginosa positive cultures is usually reduced.

Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing effect.

Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and multiple wave exposures.

The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers from prolonged antibiotics use and its possible side effects, not to mention the cost and growth of resistant bacteria. We believe that by combining ICG with light or even by light alone we can produce you a beneficial effect. Although this has been shown to kill bacteria in lab or animal studies it is still investigational for humans. The study will have two arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage (internally) followed by laser activation with a power setting of 6W. The laser will be activated with a diffuser mode meaning light of a specific known wavelength will be delivered evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50% chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly visits with a total of three visits will follow. With each visit Volunteers will receive additional treatment as the initial treatment was and a nasal culture will be taken. Volunteers will have to fill a questionnaire with each visit.

Detailed Description

A prospective randomized trial that will be performed over the period of 1 year or until 20 patients in each arm meeting inclusion criteria will be recruited. One arm will be treated with a NIR laser (ARC Lasers Gmbh, Germany) alone and another arm will have an ICG+ NIR laser treatment.

FDA approved NIR lasers in the range of 810- 980nm. FDA approved ICG (Akorn, Buffalo Grove, IL) applied locally total application will not exceed 2.5 mg Randomization method: first five volunteers will start the ICG+ laser followed by five from only laser treatment group. This will be followed by allocating one volunteer to each study arm alternatively.

Data to be collected: demographical data including age and gender, approximate duration of symptoms, culture results, SNOT 20 (QOL questionnaire) score.

Urine test will be done to rule out pregnancy prior to study enrollment. Treatment: ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments.

Non-ICG arm: same as above but without ICG appliance. Follow up will consist of an office visit upon end of treatment with an additional visit scheduled two weeks later Protective equipment: specifically designed eye goggles, draping preventing clothes stains from the dye

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rhinosinusitis
Intervention  ICMJE
  • Device: Laser + ICG
    ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments
  • Device: Laser only
    same only without ICG
Study Arms  ICMJE
  • Experimental: Laser + ICG
    ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments
    Intervention: Device: Laser + ICG
  • Active Comparator: Laser only
    same as above, without ICG
    Intervention: Device: Laser only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients over 18
  • Patients with an established nasal culture of either

    • Staph aureus,
    • Strep species,
    • Pseudo monasaureginosa,
    • Proteus.mirabilis,
    • H. influenza
    • or other intranasal pathogens.

Exclusion Criteria:

  • Patients without CRS,
  • Patients known to have Iodide allergy or ICG allergy
  • Patients scheduled for a thyroid scan
  • Pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00948519
Other Study ID Numbers  ICMJE SLR 09-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yosef Krespi, Victor Kizhner, St.Luke's-Roosevelt
Original Responsible Party Same as current
Current Study Sponsor  ICMJE New York Head & Neck Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Valam Corp.
Investigators  ICMJE Not Provided
PRS Account New York Head & Neck Institute
Verification Date July 2009

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