RhinosinusitisNCT00948519
Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
A study testing Laser + ICG and Laser only in people with Rhinosinusitis, run by New York Head & Neck Institute at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Laser + ICG and Laser only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients without CRS,
- Patients known to have Iodide allergy or ICG allergy
- Patients scheduled for a thyroid scan
- Pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
Victor Kizhner, MD contact
United States3 sites, 3 recruiting
- Recruiting
St.Luke's-Roosevelt, New York Head Neck Institute
New York, New York, 10019
Yosef Krespi, MD, 212-262-4444, hnsg@aol.com
Victor Kizhner, 212 262 44444, vkizhner@gmail.com
- Recruiting
Head Neck Surgical Group
New York, New York, 10022
- Recruiting
New York Head Neck Institute
New York, New York
Yosef Krespi, MD, 212-262-4444
Yosef Krespi, MD
About this study
Official title: Laser Microbial Killing With Photo Activated Agents
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.
Read more
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.
Read the 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
- Conditions
- Rhinosinusitis
- Being tested
- Laser + ICG, Laser only
- Keywords
- Rhinosinusitis, sinusitis, chronic, nasal polyps, phototherapy, laser,laser therapy, antibiotic, safety laser, ICG, indocyanine green, Chronic Rhinosinusitis with or without nasal polyposis
- Medical subject headings
- Rhinosinusitis, Sinusitis, Bronchiolitis Obliterans Syndrome, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser + ICGDevice
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
Laser onlyDevice
same only without ICG
| Study group | Role | What they receive |
|---|---|---|
| Laser + ICG | Experimental | 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 Receives: Device: Laser + ICG |
| Laser only | Active comparator | same as above, without ICG Receives: Device: Laser only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life improvement with disease control. Disease control without antibiotics or steroids.
Measured: 1-2 months
Secondary outcomes (1)
Laser safety without compromising disease progress
Measured: immediate and late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Head & Neck Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Valam Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948519
- Sponsor's protocol ID
- SLR 09-005
- Status last verified
- Jul 2009
- First submitted
- 28 Jul 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Omar GS, Wilson M, Nair SP. Lethal photosensitization of wound-associated microbes using indocyanine green and near-infrared light. BMC Microbiol. 2008 Jul 1;8:111. doi: 10.1186/1471-2180-8-111.
PubMed 18593460Guffey JS, Wilborn J. Effects of combined 405-nm and 880-nm light on Staphylococcus aureus and Pseudomonas aeruginosa in vitro. Photomed Laser Surg. 2006 Dec;24(6):680-3. doi: 10.1089/pho.2006.24.680.
PubMed 17199465
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Microbial Killing With Photo Activated Agents
- ClinicalTrials.gov ID
- NCT00948519
- Acronym / sponsor ID
- SLR 09-005
- Conditions
- Rhinosinusitis
- Keywords
- Rhinosinusitis, sinusitis, chronic, nasal polyps, phototherapy, laser,laser therapy, antibiotic, safety laser, ICG, indocyanine green, Chronic Rhinosinusitis with or without nasal polyposis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York Head & Neck InstituteUniversity, hospital or other
- Collaborators
- Valam Corp.
- Study start
- May 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser + ICG | Experimental | Device: Laser + ICGICG 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 |
| Laser only | Active comparator | Device: Laser onlysame as above, without ICG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients over 18
- Patients with an established nasal culture of either
Key exclusion criteria (4 listed)
- Patients without CRS,
- Patients known to have Iodide allergy or ICG allergy
- Patients scheduled for a thyroid scan
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser + ICGICG 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 + ICG |
| Laser onlysame only without ICG | Device | Laser only |
Primary outcome
Quality of Life improvement with disease control. Disease control without antibiotics or steroids.
Time frame: 1-2 months
1 secondary outcome
Laser safety without compromising disease progress
Time frame: immediate and late
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Background: PubMed 18593460Omar GS, Wilson M, Nair SP. Lethal photosensitization of wound-associated microbes using indocyanine green and near-infrared light. BMC Microbiol. 2008 Jul 1;8:111. doi: 10.1186/1471-2180-8-111.
- Background: PubMed 17199465Guffey JS, Wilborn J. Effects of combined 405-nm and 880-nm light on Staphylococcus aureus and Pseudomonas aeruginosa in vitro. Photomed Laser Surg. 2006 Dec;24(6):680-3. doi: 10.1089/pho.2006.24.680.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Kizhner, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser + ICG and Laser only in people with Rhinosinusitis, run by New York Head & Neck Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosef Krespi, MD (12122624444, hnsg@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life improvement with disease control. Disease control without antibiotics or steroids. (time frame: 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948519, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.