Sinusitis
Conditions
Keywords
sinusitis
Brief summary
This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.
Detailed description
50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. This will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. Routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. The ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.
Interventions
PROCEDUREFunctional Endoscopic Sinus Surgery with Balloon Dilatation
Luma lightwire technology will be utilized in conjunction with fluoroscopy for patients with sinusitis undergoing functional endoscopic sinus surgery with balloon dilatation. Trans-illumination of the sinus will be compared to fluoroscopy for accuracy
Sponsors
Lahey Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients needing endoscopic sinus surgery * initial or previous sinus surgery subject will be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy | at conclusion of subject enrollment |
Countries
United States
Outcome results
None listed