Trial Outcomes & Findings for In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia (NCT NCT02880514)

Last Updated: 2018-12-10

Results Overview

Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Day 30

Results posted on

2018-12-10

Participant Flow

A total of 50 participants were recruited across 12 clinical sites.

An intra-patient control design was employed where left and right frontal sinuses of each patient were randomized to the treatment or control group after successful completion of in-office balloon dilation.

Unit of analysis: sinus sides

Participant milestones

Participant milestones
Measure	PROPEL Mini Sinus Implant Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) after a successful in-office balloon dilation	Balloon Sinus Dilation Alone Successful in-office balloon dilation of the frontal sinus ostia (FSO) without implant placement
Overall Study STARTED	50 50	50 50
Overall Study COMPLETED	50 50	50 50
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=50 Participants This study used an intra-patient design with each participant having one sinus side randomized to the treatment group and the other to the control group.
Age, Continuous	56.3 years STANDARD_DEVIATION 13.76 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	49 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants
Lund-Mackay Total Score	10.8 units on a scale STANDARD_DEVIATION 3.67 • n=5 Participants
Lund-MacKay Frontal Score	1.2 units on a scale STANDARD_DEVIATION 0.40 • n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Outcome analyzed using the intent-to-treat population, which consisted of all randomized subjects and sinuses. Patency grade for 10 sinuses (6 treatment, 4 control) were missing as clinical investigators were unable to view the frontal recess/FSO, reducing the number of evaluable subjects to 44 in the treatment group and 46 in the control group.

Outcome measures

Outcome measures
Measure	PROPEL Mini Sinus Implant n=44 sinus sides Placement of the Propel Mini Sinus Implant in the frontal sinus ostia (FSO) after a successful in-office balloon dilation	Balloon Sinus Dilation Alone n=46 sinus sides Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) without implant placement
Patency Rate	38 sinus sides	33 sinus sides

SECONDARY outcome

Timeframe: Day 30

Population: Inflammation score for 7 sinuses (4 treatment, 3 control) were missing as clinical investigators were unable to view the frontal recess/FSO for 3 treatment and 2 control sinuses, and 1 participant with 1 treatment and 1 control sinuses was lost to follow-up.

Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)

Outcome measures

Outcome measures
Measure	PROPEL Mini Sinus Implant n=46 Sinuses Placement of the Propel Mini Sinus Implant in the frontal sinus ostia (FSO) after a successful in-office balloon dilation	Balloon Sinus Dilation Alone n=47 Sinuses Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) without implant placement
Inflammation Score	43.2 mm Standard Deviation 32.22	45.8 mm Standard Deviation 36.29

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=50 participants at risk An intra-patient control design with placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation compared to in-office balloon dilation without implant placement of the contralateral frontal sinus ostia (FSO) assigned to the control group.
Infections and infestations Acute sinusitis	6.0% 3/50 • Number of events 3 • Adverse event data were collected from enrollment through Day 180 post-procedure. Adverse event data were collected by clinical investigators using MedDRA terms, organized by System Organ Class.
Nervous system disorders Vision blurred	2.0% 1/50 • Number of events 1 • Adverse event data were collected from enrollment through Day 180 post-procedure. Adverse event data were collected by clinical investigators using MedDRA terms, organized by System Organ Class.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/50 • Number of events 1 • Adverse event data were collected from enrollment through Day 180 post-procedure. Adverse event data were collected by clinical investigators using MedDRA terms, organized by System Organ Class.

Additional Information

James Stambaugh, Vice President of Clinical & Medical Affairs

Intersect ENT, Inc.

Phone: 650-641-2103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place