Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery

Withdrawn before enrolling · Not applicable

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT02900794

Run by

Texas Tech University Health Sciences Center

People needed

0

Starts

2016-10-01

Expected to finish

2018-07-01

Last updated by the study team

2019-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)
• a. >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.
• 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.

You may not qualify if…

• 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)
• Polyps in nasal cavity or the middle meatus
• Prior sinus surgery, not including rhinoplasty or septoplasty
• Physician determined need for ethmoidectomy, polypectomy, septoplasty
• Patients with known immunodeficiency, ciliary dysfunction, uncontrolled diabetes (defined as most recent HgA1C > 5.7), and/or autoimmune disease
• Any clinically significant illness that may interfere with the evaluation of the study
• Patients who were involved in other clinical studies 6 months prior to the study initiation
• Patients unable to adhere to follow-up schedule or protocol requirements

Where it is running

• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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