S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Sinusitis, Nasal Polyposis

In brief

The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Key facts

Study ID

NCT02291549

Run by

Intersect ENT

People needed

300

Starts

2014-12-01

Expected to finish

2016-10-01

Last updated by the study team

2018-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patient has presence of polyposis grade 1, 1.5 or 4 on either side
• Patient has presence of adhesions/synechiae grades 3 or 4
• Patient has known history of immune deficiency
• Patient has concurrent condition such as cancer or HIV requiring active chemotherapy and/or immunotherapy management for the disease
• Patient has oral-steroid dependent condition such as COPD, asthma or other condition
• Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate
• Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for implant delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis)
• Patient has clinical evidence of acute bacterial sinusitis
• Patient has clinical evidence or suspicion of invasive fungal sinusitis
• Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day follow-up period
• Patient is currently participating in another clinical trial or has already participated in this clinical trial
• Patient has history of insulin dependent diabetes mellitus
• Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure
• Patient has known dehiscence of the lamina papyracea
• Patient has evidence of active viral illness
• Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with IOP>21 mm Hg and pressure lowering medication given) or posterior subcapsular cataract

Where it is running

• The University of Alabama Birmingham — Birmingham, Alabama, United States
• Kaiser Permanente Orange County Irvine Medical Center — Irvine, California, United States
• Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc. — Sacramento, California, United States
• Colorado ENT and Allergy — Colorado Springs, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• GW Medical Facility Associates — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• South Florida ENT — Miami, Florida, United States
• & Facial Plastic Surgery — Riverview, Florida, United States
• ENT of Georgia — Atlanta, Georgia, United States
• Northwestern Medical Faculty Foundation, Department of Otolaryngology — Chicago, Illinois, United States
• DuPage Medical Group — Naperville, Illinois, United States
• Iowa ENT Center — West Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Associated Surgical Specialists — Covington, Louisiana, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Rontal Akervall Clinic — Royal Oak, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Ear, Nose and Throat Consultants of Nevada — Las Vegas, Nevada, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• Breathe America/NM Sinus — Albuquerque, New Mexico, United States
• Albany ENT & Allergy — Albany, New York, United States
• Madison ENT & Facial Plastic Surgery — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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