Study of the Use of LUMA Lightwire

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons

NCT02509663

Frontal Sinusitis

TERMINATED NA

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

NCT01612780

Sinusitis

COMPLETED NA

Nasospore Stent For Use in Enodscopic Sinus Surgery

NCT00671541

Chronic Sinusitis

WITHDRAWN PHASE4

Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

NCT00705354

Sinusitis Chronic Sinusitis

WITHDRAWN NA

Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

NCT07032675

Nasal Valve Collapse Nose Enhancement

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE