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Study of the Use of LUMA Lightwire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00705237
Recruitment Status : Terminated (Insufficient findings for data analysis)
First Posted : June 25, 2008
Last Update Posted : February 18, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sinusitis Procedure: Functional Endoscopic Sinus Surgery with Balloon Dilatation Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: LUMA Lightwire Study
Study Start Date : March 2008
Primary Completion Date : May 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy [ Time Frame: at conclusion of subject enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00705237

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: Peter J Catalano, M.D. Lahey Clinic Medical Center

Responsible Party: Peter Catalano, M.D., Lahey Clinic Identifier: NCT00705237     History of Changes
Other Study ID Numbers: LCID 2007-118
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Lahey Clinic:

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases