Trial Outcomes & Findings for Tympanoseal (Tympanic Membrane Device) Clinical Study (NCT NCT02918942)

Last Updated: 2024-10-15

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tympanoseal All subjects will receive the Tympanoseal device. Tympanoseal: All subjects received the Tympanoseal device. Tympanoseal was placed during a surgical procedure.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tympanoseal (Tympanic Membrane Device) Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanoseal n=25 Participants All subjects will receive the Tympanoseal device. Tympanoseal: All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Age, Categorical <=18 years	25 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Tympanoseal n=25 Participants All subjects will receive the Tympanoseal device. Tympanoseal: All subjects received the Tympanoseal device. Tympanoseal was placed during a surgical procedure.
Number of Serious Adverse Events	0 Serious Adverse Event

SECONDARY outcome

Timeframe: 16 weeks

Determine if any adverse events occur during presence of material on tympanic membrane.

Outcome measures

Outcome measures
Measure	Tympanoseal n=25 Participants All subjects will receive the Tympanoseal device. Tympanoseal: All subjects received the Tympanoseal device. Tympanoseal was placed during a surgical procedure.
Number of Participants With Treatment-related Adverse Events	14 Participants

Adverse Events

Tympanoseal

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tympanoseal n=25 participants at risk All subjects will receive the Tympanoseal device. Tympanoseal: All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
Ear and labyrinth disorders Otorrhea	52.0% 13/25 • Number of events 25 • Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.
Ear and labyrinth disorders Granulation	8.0% 2/25 • Number of events 2 • Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.
Ear and labyrinth disorders Drainage	12.0% 3/25 • Number of events 3 • Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.
Ear and labyrinth disorders Otitis Externa	20.0% 5/25 • Number of events 5 • Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.
Ear and labyrinth disorders Otitis Media	4.0% 1/25 • Number of events 1 • Adverse event data was gathered at follow up visits which occurred at 4 weeks, 10 weeks, 16 weeks, 20 weeks, 24 weeks, 30 weeks, 36 weeks, 42 weeks, 48 weeks, 54 weeks as needed until the patient exited the study. Follow up visits occurred through study completion, an average of 30 weeks.

Additional Information

Robert Stroup

Grace Medical, Inc.

Phone: 901-386-0990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place