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Balloon Sinus Dilation In Office or OR

NCT00939393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-12

Study results available
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Summary

Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

FESS instruments with or without balloon treatment

Intervention with metal instruments with or without balloon treatment

DEVICE

Balloon Sinuplasty

Balloon dilatation of sinuses

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Howard Levine, MD · Rockside Road Surgery Center Independence, OH

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-01
Primary Completion
2009-06-01
Completion
2010-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939393 on ClinicalTrials.gov