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What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

NCT04902963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-05-26

No results posted yet for this study

Summary

Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

Conditions

  • Eustachian Tube Dysfunction
  • Sudden Hearing Loss
  • Meniere Disease

Interventions

DEVICE

PE tube

Gelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube.

Sponsors & Collaborators

  • Skovlund Medical Products, LLC

    lead OTHER

Principal Investigators

  • Tiffany Walker · Park Nicollet Institute, IRB Administrator

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
26 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-15
Primary Completion
2011-11-30
Completion
2011-11-30

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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 NCT04902963 on ClinicalTrials.gov