NCT00705237

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

June 23, 2008

Last Update Submit

February 17, 2009

Conditions

Sinusitis

Keywords

sinusitis

Outcome Measures

Primary Outcomes (1)

  • Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy

    at conclusion of subject enrollment

Interventions

Functional Endoscopic Sinus Surgery with Balloon DilatationPROCEDURE

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Peter J Catalano, M.D.

    Lahey Clinic Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

February 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

US(1)