Tympanoseal (Tympanic Membrane Device) Clinical Study

NCT02918942 | Completed Results

• 1 other identifier: 2015.01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

• Number of Serious Adverse Events

  The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted. An SAE is defined as any adverse event occurring that results in any of the following outcomes: 1. Death 2. A life-threatening adverse experience 3. An inpatient hospitalization or prolongation of existing hospitalization 4. A persistent or significant disability/incapacity 5. A congenital anomaly/birth defect 6. Required Intervention to Prevent Permanent Impairment or Damage

  16 weeks

Secondary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events

  16 weeks

Study Arms (1)

Tympanoseal

EXPERIMENTAL

All subjects will receive the Tympanoseal device.

Device: Tympanoseal

Interventions

Tympanoseal DEVICE

All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.

Tympanoseal

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients over 2 years of age at enrollment
• Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

You may not qualify if:

• Active otorrhea or otitis media
• History of cholesteatoma
• Perforations on the edge of the tympanic membrane
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• Subject is taking systemic corticosteroids
• Subject requires continued use of any type of topical otic medication

Sponsors & Collaborators

• Grace Medical, Inc.: lead

Study Sites (1)

UT Southwestern Medical Center

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Results Point of Contact

• Title: Robert Stroup
• Organization: Grace Medical, Inc.

robert.stroup@gracemedical.com

901-386-0990

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: October 4, 2016
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)