Study of the Use of LUMA Lightwire

This study has been terminated.
(Insufficient findings for data analysis)
Sponsor:
Information provided by:
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00705237
First received: June 23, 2008
Last updated: February 17, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: LUMA Lightwire Study

Resource links provided by NLM:


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:
    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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Lahey Clinic:
sinusitis

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

ClinicalTrials.gov processed this record on September 16, 2014