Trial Outcomes & Findings for Safety and Performance of the Steroid-Releasing S8 Sinus Implant (NCT NCT01894503)

Last Updated: 2018-07-18

Results Overview

Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

End of baseline procedure

Results posted on

2018-07-18

Participant Flow

A prospective, single-center open label study treating adult patients with recurrent polyposis after bilateral total ethmoidectomy. Study period 9 July 2013 to 17 July 2013

A total of six patients were enrolled (consented). One patient did not have the required grade 2 polyposis on at least one ethmoid side and was excluded. The remaining five patients meet all eligibility criteria and underwent an in-office bilateral placement of two S8 Sinus Implants. All five patients completed follow-up through the Day 90 visit.

Participant milestones

Participant milestones
Measure	S8 Sinus Implant Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Performance of the Steroid-Releasing S8 Sinus Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Demographic and Baseline Clinical Characteristics n=5 Participants In-office bilateral placement of two S8 Sinus Implants
Age, Continuous	46.2 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of baseline procedure

Population: Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.

Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure

Outcome measures

Outcome measures
Measure	S8 Sinus Implant n=10 Sinuses Implant delivery success
Number of Sinuses With Successful Implant Delivery	10 Sinuses

SECONDARY outcome

Timeframe: Days 3, 7, 14, 21 and 30

Population: Per-treatment evaluable population consisting of all patients

Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.

Outcome measures

Outcome measures
Measure	S8 Sinus Implant n=5 Participants Implant delivery success
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Baseline	0 participants
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Day 3	3 participants
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Day 7	1 participants
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Day 14	2 participants
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Day 21	0 participants
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ Day 30	0 participants

Adverse Events

S8 Sinus Implant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	S8 Sinus Implant n=5 participants at risk Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Adverse Events and Serious Adverse Events were recorded and tabulated through Day 90.
Infections and infestations Acute sinusitis	20.0% 1/5 • Number of events 1 • Adverse Events and Serious Adverse Events were recorded and tabulated through Day 90.

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 There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER