Trial Outcomes & Findings for Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis (NCT NCT00912405)

NCT ID: NCT00912405

Last Updated: 2015-04-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2015-04-20

Participant Flow

Participant milestones

Measure	Sinexus Intranasal Splint Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Overall Study STARTED	50
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Sinexus Intranasal Splint Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Overall Study Lost to Follow-up	5

Baseline Characteristics

Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

Baseline characteristics by cohort

Measure	Sinexus Intranasal Splint n=50 Participants Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Age, Continuous	44.2 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Lund MacKay CT Stage	11.2 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants
Proportion of Patients with Polyps	33 participants n=5 Participants
Proportion of Patients Undergoing Revision Surgery	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Measure	Sinexus Intranasal Splint n=90 number of sinuses Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)	6 Number of Sinuses Interval 2.49 to 13.95

PRIMARY outcome

Timeframe: At the time of procedure

A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.

Outcome measures

Measure	Sinexus Intranasal Splint n=90 Sinuses Attempted Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Device Placement Success Rate	90 Sinuses

SECONDARY outcome

Timeframe: Baseline and 30 days

Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.

Outcome measures

Measure	Sinexus Intranasal Splint n=50 Participants Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities	0 Pts. w/ significant IOP elevation

SECONDARY outcome

Timeframe: 30 days

Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.

Outcome measures

Measure	Sinexus Intranasal Splint n=90 Sinuses Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Number of Sinuses With Significant Post-operative Adhesion Formation	1 sinuses

Adverse Events

Sinexus Intranasal Splint

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sinexus Intranasal Splint n=50 participants at risk Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Gastrointestinal disorders Diverticulitis	2.0% 1/50 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sinusitis	4.0% 2/50 • Number of events 2

Other adverse events

Measure	Sinexus Intranasal Splint n=50 participants at risk Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
General disorders Headache	10.0% 5/50 • Number of events 5
Respiratory, thoracic and mediastinal disorders Sinusitis	36.0% 18/50 • Number of events 18

Additional Information

James Stambaugh

Intersect ENT

Phone: 650-641-2103

Email: jstambaugh@intersectent.com

Results disclosure agreements

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