Trial Outcomes & Findings for Study of the Hummingbird TTS™ Tympanostomy Tube System (NCT NCT03503591)

Results Overview

Percentage of procedures that require conversion from sedation to general anesthesia

Recruitment status

COMPLETED

Target enrollment

109 participants

Primary outcome timeframe

Intra-operative

Results posted on

2022-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Insertion of a Ventilation Tube Under Sedation and Local Anesthetic Children 6 months through 5 years of age, who are candidates for placement of VT.
Overall Study STARTED	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insertion of a Ventilation Tube Under Sedation and Local Anesthetic n=109 Participants Children 6 months through 5 years of age, who are candidates for placement of VT.
Age, Continuous	19 Months n=109 Participants
Region of Enrollment United States	109 participants n=109 Participants

PRIMARY outcome

Timeframe: Intra-operative

Percentage of procedures that require conversion from sedation to general anesthesia

Outcome measures

Outcome measures
Measure	Insertion of a Ventilation Tube Under Sedation and Local Anesthetic n=109 Participants Children 6 months through 5 years of age, who are candidates for placement of VT.
Percentage of Procedures Converted From Sedation to General Anesthesia	12.8 percentage of procedures converted Interval 7.9 to 20.6

PRIMARY outcome

Timeframe: Intra-operative

Rate of intra-operative adverse events that occur from the beginning to the end of the procedure

Outcome measures

Outcome measures
Measure	Insertion of a Ventilation Tube Under Sedation and Local Anesthetic n=109 Participants Children 6 months through 5 years of age, who are candidates for placement of VT.
Rate of Intra-operative Adverse Events	0 participants

PRIMARY outcome

Timeframe: Through discharge, estimated to be approximately 90 minutes post-procedure

Rate of adverse events that occur between the end of the procedure and discharge

Outcome measures

Outcome measures
Measure	Insertion of a Ventilation Tube Under Sedation and Local Anesthetic n=109 Participants Children 6 months through 5 years of age, who are candidates for placement of VT.
Rate of Adverse Events Through Discharge	0 percentage of AEs through discharge

Adverse Events

Insertion of a Ventilation Tube Under Sedation and Local Anesthetic

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

Steve Anderson, CEO

Preceptis Medical

Phone: 612-327-4795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place