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

NCT04902963 | Completed

• 1 other identifier: 04053-10-C
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of weeks that ventilation tube lumen is patent.

  Primary outcome was presence of a lumen, reflecting a functional device.

  0-3 months

Secondary Outcomes (1)

• Number of weeks until ventilation tube is fully resorbed.

  0-3 months

Study Arms (1)

Meeting indication for short term ventilation tube placement

EXPERIMENTAL

Adult patients meeting standard criteria for short-term ventilation tube placement were offered placement of a bioabsorbable ear tube in place of a durable ear tube that would later be removed.

Device: PE tube

Interventions

PE tube DEVICE

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.

Meeting indication for short term ventilation tube placement

Eligibility Criteria

• Age: 26 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)

You may not qualify if:

• none

Sponsors & Collaborators

• Skovlund Medical Products, LLC: lead

MeSH Terms

Conditions

Hearing Loss, Sudden; Meniere Disease

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops; Labyrinth Diseases

Study Officials

• Tiffany Walker

  Park Nicollet Institute, IRB Administrator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 2 examiners used otomicroscopy to document the function of the ear tube by documenting the number of weeks the lumen remained patent and the number of weeks until the device was fully resorbed. All examiners documented results independent of the other examiner.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: May 26, 2021
• Study Start: March 15, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 26, 2021

Record last verified: 2021-05