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

NCT ID: NCT04902963

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-15
• Study Completion Date: 2011-11-30

Brief Summary

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

Detailed Description

Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants".

14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.

Conditions

Eustachian Tube Dysfunction; Sudden Hearing Loss; Meniere Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Meeting indication for short term ventilation tube placement

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.

Group Type: EXPERIMENTAL

PE tube

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Skovlund Medical Products, LLC

OTHER

Sponsor Role: lead

Responsible Party

Sandra Skovlund

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiffany Walker

Role: STUDY_DIRECTOR

Park Nicollet Institute, IRB Administrator

Other Identifiers

04053-10-C

Identifier Type: -

Identifier Source: org_study_id