Trial Outcomes & Findings for Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse (NCT NCT02188589)

NCT ID: NCT02188589

Last Updated: 2019-03-26

Results Overview

Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Treatment Group Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Overall Study STARTED	30
Overall Study 6 Months	30
Overall Study 12 Months	30
Overall Study 24 Months	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Treatment Group Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Baseline characteristics by cohort

Measure	Treatment Group n=30 Participants Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Age, Continuous	51.1 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

Outcome measures

Measure	Treatment Group n=30 Participants Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Implant-related Adverse Events	5 participants

SECONDARY outcome

Timeframe: At baseline and at 6, 12, and 24 months post implant

Population: All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.

Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).

Outcome measures

Measure	Treatment Group n=30 Participants Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Breathing Capacity (NOSE Scores) Baseline	76.7 scores on a scale Standard Deviation 14.8
Breathing Capacity (NOSE Scores) 6 Months	33.3 scores on a scale Standard Deviation 29.7
Breathing Capacity (NOSE Scores) 12 Months	35.2 scores on a scale Standard Deviation 29.2
Breathing Capacity (NOSE Scores) 24 Months	32.0 scores on a scale Standard Deviation 29.3

SECONDARY outcome

Timeframe: At 6, 12, and 24 months post implant

Population: All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.

Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.

Outcome measures

Measure	Treatment Group n=30 Participants Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
NOSE Responder Rate 6 Months	80.0 percentage of responders
NOSE Responder Rate 12 Months	76.7 percentage of responders
NOSE Responder Rate 24 Months	80.0 percentage of responders

Adverse Events

Treatment Group

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=30 participants at risk Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Investigations Nonsurgical implant retrieval	10.0% 3/30 • Number of events 3 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Surgical and medical procedures Hernia Repair Procedure	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Respiratory, thoracic and mediastinal disorders Bronchitis	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.

Other adverse events

Measure	Treatment Group n=30 participants at risk Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)
Skin and subcutaneous tissue disorders Hematoma	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Skin and subcutaneous tissue disorders Inflammation	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
General disorders Rhinitis	10.0% 3/30 • Number of events 3 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
General disorders Rhinorrhea	6.7% 2/30 • Number of events 2 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Vascular disorders Acute hypertension	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Social circumstances Injury by fallen tree	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
General disorders Vertigo	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
General disorders Headache	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.
Blood and lymphatic system disorders Normal Bleeding Epistaxis	3.3% 1/30 • Number of events 1 • Through 24 months post implant Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: ellen.omalley@stryker.com

Results disclosure agreements

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