SinusitisNCT02900794
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery
A study testing Gold Laser and Microdebridement in people with Sinusitis, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Sinusitis is a common medical problem, which significantly decreases patients' quality of life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion and drainage, decreased sense of smell, and malaise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinusitis
- What is being tested?
- Gold Laser and Microdebridement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2018
- 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
- Study will include subjects age 18 or older with chronic rhinosinusitis as described by the guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS).
- Males and females aged 18 or greater
- Chronic rhinosinusitis as described by the guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS)
- >12 weeks of two or more of the following signs i. mucopurulent drainage (anterior, posterior, or both) ii. nasal obstruction or congestion iii. facial pain/pressure or fullness, or iv. decreased ability to smell b. AND inflammation is documented by one or more of the following findings i. Purulent mucus or edema in the middle meatus or ethmoid region ii. Radiographic imaging showing inflammation of the paranasal sinuses
- At least one episode of CRS documented in study investigator's practice with an endoscopic examination with purulent drainage and edema at the time consistent with CRS
- Radiographic evidence of sinus inflammation during chronic bacterial rhinosinusitis indicating sinus disease at the ostiomeatal complex.
Show all 9Show fewer
- Willing and able to read and sign informed consent form and remain compliant with the protocol and study procedures
- Able to read and understand English
- Patients whom are planning to have functional endoscopic sinus surgery.
Who cannot join
- 1. Diagnosis of Acute Rhinosinusitis or recurrent acute rhinosinusitis
- per guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS)
- 2. Polyps in nasal cavity or the middle meatus
- 3. Prior sinus surgery, not including rhinoplasty or septoplasty
- 4. Physician determined need for ethmoidectomy, polypectomy, septoplasty
- 5. Patients with known immunodeficiency, ciliary dysfunction, uncontrolled diabetes (defined as most recent HgA1C > 5.7), and/or autoimmune disease
Show all 9Show fewer
- 6. Any clinically significant illness that may interfere with the evaluation of the study
- 7. Patients who were involved in other clinical studies 6 months prior to the study initiation
- 8. Patients unable to adhere to follow-up schedule or protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Comparing Post-Operative Outcomes Between Gold Laser and Micro-Debriders for Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Sinusitis is a common medical problem, which significantly decreases patients' quality of life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion and drainage, decreased sense of smell, and malaise. Surgical therapy for sinusitis attempts to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization, illumination, and magnification of the sinuses and adjacent structures. There are a variety of surgical instruments available to a surgeon for ESS such as stainless steel tools (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been shown to improve QOL, decrease medication use and days missed at work for subjects. The use of lasers in treatment of chronic sinus infections is well documented. The LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing), post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates and compare postoperative outcomes with the use of a microdebrider. These uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.
Read the detailed description
Sinusitis is a common medical problem, which significantly decreases patients' quality of life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion and drainage, decreased sense of smell, and malaise. In the United States annually, 30 million cases of sinusitis are diagnosed with an occurrence of 1 in 8 adults. The direct medical costs are estimated at $2.4 billion per year with indirect costs reaching upwards of $5 billion. Rhinosinusitis is described as the symptomatic inflammation of the paranasal sinuses and nasal cavity. The term rhinosinusitis is preferred because most sinusitis is accompanied by inflammation of the contiguous nasal mucosa. Uncomplicated rhinosinusitis is defined as rhinosinusitis without clinically evident extension of inflammation outside the paranasal sinuses and nasal cavity at the time of diagnosis (e.g. no neurologic, ophthalmologic, or soft tissue involvement). Rhinosinusitis may be classified by duration as acute rhinosinusitis (ARS) (<4 weeks' duration) or as chronic rhinosinusitis (CRS) (>12 weeks), with or without acute exacerbations. This condition can resolve spontaneously, but often requires antibiotics and/or steroids, which is successful in a majority of patients. Sinus surgery is therefore indicated in patients whose symptoms persist despite conservative medical management. A guideline providing evidence-based recommendations for the diagnosis and management of adult sinusitis was developed and revised by a panel of physicians, nurses, and healthcare professionals under the support of the American Academy of Otolaryngology - Head and Neck Surgery.
Surgical therapy for sinusitis attempts to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization, illumination, and magnification of the sinuses and adjacent structures. This "endoscopic sinus surgery" or (ESS) techniques have been developed to treat four types of sinuses (maxillary, frontal, sphenoid, and ethmoid). The variability of involvement of the sinuses vary from patient to patient. There are a variety of surgical instruments available to a surgeon for ESS such as stainless steel tools (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been shown to improve QOL, decrease medication use and days missed at work for subjects.
The use of lasers has shown to be beneficial in several otolaryngological procedures. The LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various head and neck surgical procedures including functional endoscopic sinus surgery. With the use of the LF-40 Gold Laser, this study is being performed with the intentions of comparing post-operative outcomes with sinus surgeries performed using a microdebrider.
The purpose of this study will be to determine if post operative outcomes while utilizing the gold laser for performing excision of the concha bullosa, maxillary antrostomy, and submucosal cauterization of the turbinates are significantly improved as compared to use of microdebrider for sinus surgeries. The investigators aim to determine the treatment outcomes 2 weeks, 2 months, and 6 months postoperatively as compared to use of a microdebrider.
- Conditions
- Sinusitis
- Being tested
- Gold Laser, Microdebridement
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold LaserDevice
Under endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary.
MicrodebridementProcedure or surgery
Under endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates.
| Study group | Role | What they receive |
|---|---|---|
| Contrast Arm (Microdebridement) | Other | Typical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. Receives: Procedure: Microdebridement |
| Treatment Arm (Gold Laser) | Other | Typical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. If the Investigator determines that the sinus is not sufficiently dilated or cannot be accessed, the need for and the type of additional treatment will be at the discretion of the Investigator. Receives: Device: Gold Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Chronic Sinusitis Survey (CSS) Score
Comparison will be made of change in patient-reported quality of life (QOL) as measured by Total CSS score at 2 weeks, 8 weeks, and 24 weeks postoperatively for subjects randomized to micro-debridement versus gold laser.
Measured: 2 weeks, 8 weeks, 24 weeks
Secondary outcomes (4)
Rhinosinusitis Disability Index (RSDI) Score
Comparison will be made of change in patient-reported quality of life (QOL) as measured by rhinosinusitis disability index (RSDI) total, physical, functional, and emotional sub-scores at 2 weeks, 8 weeks, and 24 weeks postoperatively for subjects randomized to microdebridement versus gold laser
Measured: 2 weeks, 8 weeks, 24 weeks
Number of Patients Reporting Use of Sinusitis Related Medications Post-Surgically (Medications include: Oral antibiotics, Oral steroids, Topical intranasal steroid sprays, Topical and Nasal Anti-histamines)
Comparison will be made of medication type (name), dosage, frequency, and route of administration at 8 weeks and 24 weeks postoperatively (days of oral antibiotics, oral steroids, topical intranasal steroid sprays, topical and nasal anti-histamines) for subjects randomized to microdebridement versus gold laser.
Measured: 8 weeks, 24 weeks
Days Missed At Work/School
Comparison will be made of missed days at work/school and unscheduled medical care visits due to sinusitis at 8 weeks and 24 weeks postoperatively for subjects randomized to microdebridement versus gold laser.
Measured: 8 weeks, 24 weeks
Number of Sinus Infections
Comparison will be made of patient reported pre-post-enrollment sinus infections and patient-reported sinus infection severity for subjects randomized to microdebridement versus gold laser
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joehassin Cordero, MD, Principal investigator, TTUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900794
- Sponsor's protocol ID
- L16-117
- Status last verified
- Dec 2019
- First submitted
- 22 Aug 2016
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gerlinger I, Lujber L, Jarai T, Pytel J. KTP-532 laser-assisted endoscopic nasal sinus surgery. Clin Otolaryngol Allied Sci. 2003 Apr;28(2):67-71. doi: 10.1046/j.1365-2273.2003.00660.x.
PubMed 12680820Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
PubMed 24819891Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. doi: 10.1016/s0194-5998(03)01397-4. No abstract available.
PubMed 12958561McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.
PubMed 7807660Snow V, Mottur-Pilson C, Hickner JM; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine; Centers for Disease Control; Infectious Diseases Society of America. Principles of appropriate antibiotic use for acute sinusitis in adults. Ann Intern Med. 2001 Mar 20;134(6):495-7. doi: 10.7326/0003-4819-134-6-200103200-00016. No abstract available.
PubMed 11255527Bhattacharyya N. Chronic rhinosinusitis: is the nose really involved? Am J Rhinol. 2001 May-Jun;15(3):169-73. doi: 10.2500/105065801779954184.
PubMed 11453503Poetker DM, Litvack JR, Mace JC, Smith TL. Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):329-33. doi: 10.2500/ajr.2008.22.3177.
PubMed 18588769Metson R. Holmium:YAG laser endoscopic sinus surgery: a randomized, controlled study. Laryngoscope. 1996 Jan;106(1 Pt 2 Suppl 77):1-18. doi: 10.1097/00005537-199601001-00001.
PubMed 8538352Lee JC, Lai WS, Ju DT, Chu YH, Yang JM. Diode laser assisted minimal invasive sphenoidotomy for endoscopic transphenoidal pituitary surgery: our technique and results. Lasers Surg Med. 2015 Mar;47(3):239-42. doi: 10.1002/lsm.22340.
PubMed 25810080Chester AC, Sindwani R. Symptom outcomes in endoscopic sinus surgery: a systematic review of measurement methods. Laryngoscope. 2007 Dec;117(12):2239-43. doi: 10.1097/MLG.0b013e318149224d.
PubMed 18322425Alobid I, Bernal-Sprekelsen M, Mullol J. Chronic rhinosinusitis and nasal polyps: the role of generic and specific questionnaires on assessing its impact on patient's quality of life. Allergy. 2008 Oct;63(10):1267-79. doi: 10.1111/j.1398-9995.2008.01828.x.
PubMed 18782106Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001 Jan-Feb;15(1):15-20. doi: 10.2500/105065801781329428.
PubMed 11258649Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1175-9. doi: 10.1001/archotol.1997.01900110025004.
PubMed 9366696Soler ZM, Hyer JM, Karnezis TT, Schlosser RJ. The Olfactory Cleft Endoscopy Scale correlates with olfactory metrics in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):293-8. doi: 10.1002/alr.21655. Epub 2015 Dec 31.
PubMed 26718315Rudmik L, Hopkins C, Peters A, Smith TL, Schlosser RJ, Soler ZM. Patient-reported outcome measures for adult chronic rhinosinusitis: A systematic review and quality assessment. J Allergy Clin Immunol. 2015 Dec;136(6):1532-1540.e2. doi: 10.1016/j.jaci.2015.10.012.
PubMed 26654198
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post-Operative Outcomes Between Gold Laser and Micro-Debriders for Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT02900794
- Acronym / sponsor ID
- L16-117
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Sep 2016 (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.
Sinusitis is a common medical problem, which significantly decreases patients' quality of life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion and drainage, decreased sense of smell, and malaise. Surgical therapy for sinusitis attempts to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization, illumination, and magnification of the sinuses and adjacent structures. There are a variety of surgical instruments available to a surgeon for ESS such as stainless steel tools (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been shown to improve QOL, decrease medication use and days missed at work for subjects. The use of lasers in treatment of chronic sinus infections is well documented. The LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing), post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates and compare postoperative outcomes with the use of a microdebrider. These uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.
Detailed description
Sinusitis is a common medical problem, which significantly decreases patients' quality of life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion and drainage, decreased sense of smell, and malaise. In the United States annually, 30 million cases of sinusitis are diagnosed with an occurrence of 1 in 8 adults. The direct medical costs are estimated at $2.4 billion per year with indirect costs reaching upwards of $5 billion. Rhinosinusitis is described as the symptomatic inflammation of the paranasal sinuses and nasal cavity. The term rhinosinusitis is preferred because most sinusitis is accompanied by inflammation of the contiguous nasal mucosa. Uncomplicated rhinosinusitis is defined as rhinosinusitis without clinically evident extension of inflammation outside the paranasal sinuses and nasal cavity at the time of diagnosis (e.g. no neurologic, ophthalmologic, or soft tissue involvement). Rhinosinusitis may be classified by duration as acute rhinosinusitis (ARS) (<4 weeks' duration) or as chronic rhinosinusitis (CRS) (>12 weeks), with or without acute exacerbations. This condition can resolve spontaneously, but often requires antibiotics and/or steroids, which is successful in a majority of patients. Sinus surgery is therefore indicated in patients whose symptoms persist despite conservative medical management. A guideline providing evidence-based recommendations for the diagnosis and management of adult sinusitis was developed and revised by a panel of physicians, nurses, and healthcare professionals under the support of the American Academy of Otolaryngology - Head and Neck Surgery.
Surgical therapy for sinusitis attempts to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization, illumination, and magnification of the sinuses and adjacent structures. This "endoscopic sinus surgery" or (ESS) techniques have been developed to treat four types of sinuses (maxillary, frontal, sphenoid, and ethmoid). The variability of involvement of the sinuses vary from patient to patient. There are a variety of surgical instruments available to a surgeon for ESS such as stainless steel tools (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been shown to improve QOL, decrease medication use and days missed at work for subjects.
The use of lasers has shown to be beneficial in several otolaryngological procedures. The LF-40 Gold Laser (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various head and neck surgical procedures including functional endoscopic sinus surgery. With the use of the LF-40 Gold Laser, this study is being performed with the intentions of comparing post-operative outcomes with sinus surgeries performed using a microdebrider.
The purpose of this study will be to determine if post operative outcomes while utilizing the gold laser for performing excision of the concha bullosa, maxillary antrostomy, and submucosal cauterization of the turbinates are significantly improved as compared to use of microdebrider for sinus surgeries. The investigators aim to determine the treatment outcomes 2 weeks, 2 months, and 6 months postoperatively as compared to use of a microdebrider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contrast Arm (Microdebridement) | Other | Procedure: MicrodebridementTypical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. |
| Treatment Arm (Gold Laser) | Other | Device: Gold LaserTypical pre-operative intervention including injectable local anesthetic into the inferior and middle turbinates followed by topical anesthetic on soaked cottonoids or pledgets placed in the nasal cavity floor, medial to the middle turbinate, behind the uncinate process will be performed. Using endoscopy, the nasal passage is located. Under endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. If the Investigator determines that the sinus is not sufficiently dilated or cannot be accessed, the need for and the type of additional treatment will be at the discretion of the Investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Study will include subjects age 18 or older with chronic rhinosinusitis as described by the guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS).
Key exclusion criteria (9 listed)
- 1. Diagnosis of Acute Rhinosinusitis or recurrent acute rhinosinusitis
- 2. Polyps in nasal cavity or the middle meatus
- 3. Prior sinus surgery, not including rhinoplasty or septoplasty
- 4. Physician determined need for ethmoidectomy, polypectomy, septoplasty
- 5. Patients with known immunodeficiency, ciliary dysfunction, uncontrolled diabetes (defined as most recent HgA1C > 5.7), and/or autoimmune disease
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 |
|---|---|---|
| Gold LaserUnder endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary. | Device | Treatment Arm (Gold Laser) |
| MicrodebridementUnder endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. | Procedure or surgery | Contrast Arm (Microdebridement) |
Primary outcome
Total Chronic Sinusitis Survey (CSS) Score
Time frame: 2 weeks, 8 weeks, 24 weeks
Comparison will be made of change in patient-reported quality of life (QOL) as measured by Total CSS score at 2 weeks, 8 weeks, and 24 weeks postoperatively for subjects randomized to micro-debridement versus gold laser.
4 secondary outcomes
Rhinosinusitis Disability Index (RSDI) Score
Time frame: 2 weeks, 8 weeks, 24 weeks
Number of Patients Reporting Use of Sinusitis Related Medications Post-Surgically (Medications include: Oral antibiotics, Oral steroids, Topical intranasal steroid sprays, Topical and Nasal Anti-histamines)
Time frame: 8 weeks, 24 weeks
Days Missed At Work/School
Time frame: 8 weeks, 24 weeks
Number of Sinus Infections
Time frame: 24 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 12680820Gerlinger I, Lujber L, Jarai T, Pytel J. KTP-532 laser-assisted endoscopic nasal sinus surgery. Clin Otolaryngol Allied Sci. 2003 Apr;28(2):67-71. doi: 10.1046/j.1365-2273.2003.00660.x.
- Background: PubMed 24819891Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
- Background: PubMed 12958561Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. doi: 10.1016/s0194-5998(03)01397-4. No abstract available.
- Background: PubMed 7807660McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.
- Background: PubMed 11255527Snow V, Mottur-Pilson C, Hickner JM; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine; Centers for Disease Control; Infectious Diseases Society of America. Principles of appropriate antibiotic use for acute sinusitis in adults. Ann Intern Med. 2001 Mar 20;134(6):495-7. doi: 10.7326/0003-4819-134-6-200103200-00016. No abstract available.
- Background: PubMed 11453503Bhattacharyya N. Chronic rhinosinusitis: is the nose really involved? Am J Rhinol. 2001 May-Jun;15(3):169-73. doi: 10.2500/105065801779954184.
- Background: PubMed 18588769Poetker DM, Litvack JR, Mace JC, Smith TL. Recurrent acute rhinosinusitis: presentation and outcomes of sinus surgery. Am J Rhinol. 2008 May-Jun;22(3):329-33. doi: 10.2500/ajr.2008.22.3177.
- Background: PubMed 8538352Metson R. Holmium:YAG laser endoscopic sinus surgery: a randomized, controlled study. Laryngoscope. 1996 Jan;106(1 Pt 2 Suppl 77):1-18. doi: 10.1097/00005537-199601001-00001.
- Background: PubMed 25810080Lee JC, Lai WS, Ju DT, Chu YH, Yang JM. Diode laser assisted minimal invasive sphenoidotomy for endoscopic transphenoidal pituitary surgery: our technique and results. Lasers Surg Med. 2015 Mar;47(3):239-42. doi: 10.1002/lsm.22340.
- Background: PubMed 18322425Chester AC, Sindwani R. Symptom outcomes in endoscopic sinus surgery: a systematic review of measurement methods. Laryngoscope. 2007 Dec;117(12):2239-43. doi: 10.1097/MLG.0b013e318149224d.
- Background: PubMed 18782106Alobid I, Bernal-Sprekelsen M, Mullol J. Chronic rhinosinusitis and nasal polyps: the role of generic and specific questionnaires on assessing its impact on patient's quality of life. Allergy. 2008 Oct;63(10):1267-79. doi: 10.1111/j.1398-9995.2008.01828.x.
- Background: PubMed 11258649Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001 Jan-Feb;15(1):15-20. doi: 10.2500/105065801781329428.
- Sinus Surgery \[Internet\]. Pensacola: Medical Energy Inc.; c2015 \[cited 2016 March 24\]Link provided by the sponsor.
- Winters R, Knight Worley N. Gold Laser Resection of the Concha Bullosa: Description of a New Technique. Otolaryngology. 2012; 2:2.Link provided by the sponsor.
- Stavem K, Rossberg E, Larsson P. Reliability, validity and responsiveness of a Norwegian Version of the Chronic Sinusitis Survey. BMC Ear, Nose and Throat Disorders. 2006; 6:9.Link provided by the sponsor.
- 1\. Ware, JE. The SF-36 Health Survey Manual and Interpretation Guide. Nimrod Press, Boston 1993; pp 10-14Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease
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.
Joehassin Cordero, MD principal investigator
TTUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold Laser and Microdebridement in people with Sinusitis, run by Texas Tech University Health Sciences Center at 1 site 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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Chronic Sinusitis Survey (CSS) Score (time frame: 2 weeks, 8 weeks, 24 weeks). 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 NCT02900794, which also lists 19 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 10 Dec 2019.