Study of the Use of LUMA Lightwire

Phase 4

Terminated

• Conditions: Sinusitis

• Registration Number: NCT00705237
• Lead Sponsor: Lahey Clinic

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-05
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients needing endoscopic sinus surgery
• initial or previous sinus surgery subject will be included

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy	at conclusion of subject enrollment

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States