Study of the Use of LUMA Lightwire

Sinusitis Clinical Trial

Official title:

LUMA Lightwire Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705237
• Other study ID #: LCID 2007-118
• Status: Terminated
• Phase: Phase 4
• First received: June 23, 2008
• Last updated: February 17, 2009
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients needing endoscopic sinus surgery

• initial or previous sinus surgery subject will be included

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy		at conclusion of subject enrollment	Yes