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Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

NCT02087150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2024-07-12

Study results available
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Summary

The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.

Conditions

  • Eustachian Tube Dysfunction

Interventions

DEVICE

Acclarent Eustachian Tube Balloon Catheter (ETBC)

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Dennis Poe, MD, PhD · Boston Children's Hospital

  • Vijay Anand, MD · Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-01
Primary Completion
2016-12-01
Completion
2017-01-12
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 NCT02087150 on ClinicalTrials.gov