Trial Outcomes & Findings for Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium (NCT NCT01623050)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Immediately post procedure

Results posted on

2014-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	SinuSys Dilation System Maxillary Sinus Dilation
Overall Study STARTED	36
Overall Study Treated	34
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	SinuSys Dilation System Maxillary Sinus Dilation
Overall Study Lost to Follow-up	9

Baseline Characteristics

Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSys Dilation System n=34 Participants Maxillary Sinus Dilation SinuSys Dilation System: Sinuplasty
Age, Continuous	45.1 years STANDARD_DEVIATION 16.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post procedure

Population: Number of osita treated

Outcome measures

Outcome measures
Measure	SinuSys Dilation System n=59 Ostia Maxillary Sinus Dilation
Patency of Treated Area	95 percentage of ostia treated

SECONDARY outcome

Timeframe: 3 months

Population: One patient was lost to follow up

Maxillary Sinus Ostia Patency of 33 patients analyzed.

Outcome measures

Outcome measures
Measure	SinuSys Dilation System n=55 Ostia Maxillary Sinus Dilation
Patency of Treated Area	93 percentage of ostia patent

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	SinuSys Dilation System n=34 Participants Maxillary Sinus Dilation
Number of Participants With Device-related Adverse Events as a Measure of Safety	0 number of participants

SECONDARY outcome

Timeframe: 6 months

Population: 5 patients were lost to follow up

Maxillary Sinus Ostia Patency of 29 patients analyzed.

Outcome measures

Outcome measures
Measure	SinuSys Dilation System n=47 Ostia Maxillary Sinus Dilation
Patency of Treated Area	91 percentage of ostia patent

SECONDARY outcome

Timeframe: 12 months

Population: 7 patients were lost to follow up

Maxillary Sinus Ostia of 27 patients analyzed.

Outcome measures

Outcome measures
Measure	SinuSys Dilation System n=45 Ostia Maxillary Sinus Dilation
Patency of Treated Area	93 percentage of ostia patent

Adverse Events

SinuSys Dilation System

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

Janie Mandrusov, Director of Pre-Clinical and Clinical Development

SinuSys Corporation

Phone: 4084104411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60