A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

NCT00840970 | Completed Results

• 1 other identifier: P500-0208
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

• Device Success Rate

  Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.

  Baseline

• Reduction in Ethmoid Sinus Inflammation

  Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".

  21 days

Secondary Outcomes (4)

• Middle Turbinate Lateralization

  30 days

• Middle Meatus Patency

  30 days

• Significant Adhesion Occurrence

  30 days

• Polypoid Tissue Changes

  30 days

Study Arms (3)

Efficacy Unilateral Control

ACTIVE COMPARATOR

Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm)

Device: non-coated Intranasal Splint

Efficacy Unilateral Treatment

EXPERIMENTAL

Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm)

Device: Sinexus Intranasal Splint

Safety/PK Bilateral Treatment

EXPERIMENTAL

Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS

Device: Sinexus Intranasal Splint

Interventions

non-coated Intranasal Splint DEVICE

placement of non-coated intranasal splint following FESS

Efficacy Unilateral Control

Sinexus Intranasal Splint DEVICE

placement of Sinexus Intranasal Splint placed following FESS

Efficacy Unilateral Treatment; Safety/PK Bilateral Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age or older.
• Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
• Patient has a clinical indication for and has consented to bilateral FESS.
• CRS diagnosis documented by CT scan within 60 days of the procedure.
• Patient has minimal total CT stage (Lund-Mackay method) of 6.
• Patient has bilateral disease defined as minimal CT stage per side of ≥3.

You may not qualify if:

• Oral-Steroid dependent COPD, asthma or other condition.
• Immune deficiency (IGG subclass deficiency or IGA deficiency).
• Symptomatic coronary artery disease.
• Patient undergoing chemotherapy treatment.
• Morbid obesity (BMI \> 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
• Evidence of active infection.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (1)

Central California Ear, Nose, Throat

Fresno, California, 93720, United States

Location

Results Point of Contact

• Title: Chris Lewis, VP Clinical Affairs
• Organization: Intersect ENT

clewis@intersectent.com

423-598-6681

Study Officials

• Brent Lanier, MD

  Central California Ear, Nose, Throat

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Locations

US (1)