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

NCT02900794 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-10

No results posted yet for this study

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. 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.

Conditions

  • Sinusitis

Interventions

DEVICE

Gold Laser

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.

PROCEDURE

Microdebridement

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.

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Joehassin Cordero, MD · TTUHSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900794 on ClinicalTrials.gov