Study of the Use of LUMA Lightwire - Full Text View

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00705237

Purpose

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	Intervention	Phase
Sinusitis	Procedure: Functional Endoscopic Sinus Surgery with Balloon Dilatation	Phase IV

MedlinePlus related topics: Sinusitis Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	LUMA Lightwire Study

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy [ Time Frame: at conclusion of subject enrollment ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	March 2008
Study Completion Date:	February 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705237

Locations

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

Lahey Clinic

Investigators

Principal Investigator:

Peter J Catalano, M.D.

Lahey Clinic Medical Center

More Information

No publications provided

Responsible Party:	Lahey Clinic ( Peter Catalano, M.D. )
Study ID Numbers:	LCID 2007-118
Study First Received:	June 23, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00705237 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

sinusitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Sinusitis

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Paranasal Sinus Diseases
Sinusitis
Nose Diseases

ClinicalTrials.gov processed this record on May 06, 2009