Study of the Use of LUMA Lightwire

Overview

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.

Full Title of Study: “LUMA Lightwire Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2008

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

  • Procedure: Functional 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

Clinical Trial Outcome Measures

Primary Measures

  • Time, ease and accuracy of placement – compare accuracy of trans-illumination with fluoroscopy
    • Time Frame: at conclusion of subject enrollment

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lahey Clinic
  • Provider of Information About this Clinical Study
    • Peter Catalano, M.D., Lahey Clinic
  • Overall Official(s)
    • Peter J Catalano, M.D., Principal Investigator, Lahey Clinic Medical Center

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