Trial Outcomes & Findings for In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old (NCT NCT03544138)

NCT ID: NCT03544138

Last Updated: 2022-12-14

Results Overview

AEs that occurred from enrollment through the 3-10 week follow-up were collected.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 258 participants
• Primary outcome timeframe: Follow-up between 3-10 weeks
• Results posted on: 2022-12-14

Participant Flow

Unit of analysis: Number of ears

Participant milestones

Measure	Hummingbird Tympanostomy Tube System (H-TTS) Tube Delivery Subjects will have ear tubes placed with the Hummingbird Tympanostomy Tube System (H-TTS) in an office setting using topical anesthetic.
Overall Study STARTED	258 492
Overall Study COMPLETED	229 440
Overall Study NOT COMPLETED	29 52

Reasons for withdrawal

Measure	Hummingbird Tympanostomy Tube System (H-TTS) Tube Delivery Subjects will have ear tubes placed with the Hummingbird Tympanostomy Tube System (H-TTS) in an office setting using topical anesthetic.
Overall Study Lost to Follow-up	29

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hummingbird Tympanostomy Tube System (H-TTS) n=258 Participants The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
Age, Categorical <=18 years	258 Participants n=258 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=258 Participants
Age, Categorical >=65 years	0 Participants n=258 Participants
Sex: Female, Male Female	110 Participants n=258 Participants
Sex: Female, Male Male	148 Participants n=258 Participants
Region of Enrollment United States	258 participants n=258 Participants

PRIMARY outcome

Timeframe: Follow-up between 3-10 weeks

Population: Rate of ears experiencing an adverse event. There were 258 participants and 492 ears analyzed.

AEs that occurred from enrollment through the 3-10 week follow-up were collected.

Outcome measures

Measure

Hummingbird Tympanostomy Tube System (H-TTS) n=492 Ears The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up

0.41 percentage of ears

PRIMARY outcome

Timeframe: Intra-Procedure

Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.

Outcome measures

Measure

Hummingbird Tympanostomy Tube System (H-TTS) n=492 Ears The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS

97.2 percentage of ears

PRIMARY outcome

Timeframe: Intra-procedure

Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.

Outcome measures

Measure

Hummingbird Tympanostomy Tube System (H-TTS) n=258 Participants The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Percentage of Participants With Successful Completion of Procedure In-office

98.4 percentage of participants

Adverse Events

Hummingbird Tympanostomy Tube System (H-TTS)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hummingbird Tympanostomy Tube System (H-TTS) n=258 participants at risk The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
Surgical and medical procedures Acute tube extrusion	0.39% 1/258 • Number of events 1 • All adverse events (AE), both anticipated and unanticipated, were reported through follow-up of 3-10 weeks.
Surgical and medical procedures Tube dislocating into middle ear space	0.39% 1/258 • Number of events 1 • All adverse events (AE), both anticipated and unanticipated, were reported through follow-up of 3-10 weeks.

Additional Information

Steve Anderson

Preceptis Medical

Phone: 612-327-4795

Email: steve@preceptismedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place