Trial Outcomes & Findings for Hummingbird TTS Ear Tube Delivery Study (NCT NCT02165384)

NCT ID: NCT02165384

Last Updated: 2019-01-03

Results Overview

Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 199 participants
• Primary outcome timeframe: intra operative
• Results posted on: 2019-01-03

Participant Flow

Participant milestones

Measure	Hummingbird TTS Treatment only surgical instrument study
Overall Study STARTED	199
Overall Study COMPLETED	199
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hummingbird TTS Ear Tube Delivery Study

Baseline characteristics by cohort

Measure	Hummingbird TTS n=199 Participants Treatment only surgical instrument study
Age, Customized	20 months n=93 Participants
Sex: Female, Male Female	NA Participants n=93 Participants
Sex: Female, Male Male	NA Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	199 Participants n=93 Participants
Region of Enrollment United States	199 participants n=93 Participants

PRIMARY outcome

Timeframe: intra operative

Population: 393 ears in 199 patients received ear tube placement from the Hummingbird device.

Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.

Outcome measures

Measure	Hummingbird TTS n=393 Ears Treatment only HTTS was used to make incision and deliver ear tube
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane	393 Ears

PRIMARY outcome

Timeframe: Intra-operative

Any intra-operative adverse events, anticipated or unanticipated

Outcome measures

Measure	Hummingbird TTS n=199 Participants Treatment only HTTS was used to make incision and deliver ear tube
Number of Participants With Intra-operative Adverse Events	0 Participants

Adverse Events

Hummingbird TTS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CEO

Preceptis Medical

Phone: 6123274795

Email: steve@preceptismedical.com

Results disclosure agreements

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