A Clinical Evaluation of PROPEL® Contour Sinus Implant (EXPAND)

Intersect ENT

Status: Completed

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Device: PROPEL Contour Sinus Implant; Procedure: Balloon Sinus Dilation Alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04858802

P500-1220

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

Full description

A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.

After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patient is 18 years of age or older.
2. Patient is willing and able to comply with protocol requirements.
3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
4. Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.
5. A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO

Exclusion criteria

1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 2) unless reduced 30 days prior to the baseline procedure
3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
4. Known history of allergy or intolerance to corticosteroids or mometasone furoate.
5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
6. Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.
7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
8. Patients with implantable, body worn devices such as insulin pumps.
9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
11. Active viral illness (e.g., flu, shingles).
12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

PROPEL Contour Sinus Implant

Experimental group

Description:

Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.

Treatment:

Device: PROPEL Contour Sinus Implant

Balloon Sinus Dilation Alone

Active Comparator group

Description:

Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.

Treatment:

Procedure: Balloon Sinus Dilation Alone