Tympanic Membrane Perforation
Conditions
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.
Detailed description
This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.
Interventions
DEVICETympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Sponsors
Grace Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Events | 16 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 16 weeks | Determine if any adverse events occur during presence of material on tympanic membrane. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tympanoseal All subjects will receive the Tympanoseal device.
Tympanoseal: All subjects will receive the Tympanoseal device that will be placed during a surgical procedure. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Tympanoseal |
|---|---|
| Age, Categorical <=18 years | 25 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 14 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanoseal | Number of Serious Adverse Events | 0 Serious Adverse Event |
Secondary
Number of Participants With Treatment-related Adverse Events
Determine if any adverse events occur during presence of material on tympanic membrane.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanoseal | Number of Participants With Treatment-related Adverse Events | 14 Participants |