Ear, Nose and Throat (Otolaryngology) – Head and Neck Surgery

Rhinology, Sinus Surgery and Allergy Research and Clinical Trials

Researchers at Mount Sinai’s Division of Rhinology, Sinus Surgery and Allergy are dedicated to improving patient treatments and outcomes through clinical trials and translational studies. These efforts include employing new medical therapies and embracing the least invasive treatments to help get patients back to their daily routines as quickly and effectively as possible. The following are clinical trials offered to patients suffering from chronic sinusitis:

Recurrent Nasal Polyps and Chronic Sinusitis: The Department of Otolaryngology is seeking adults with sinus disease and polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in one of two clinical trials at Mount Sinai, which offer a cutting-edge therapy to help reduce symptoms and avoid surgery.

The treatment combines an antibiotic (doxycycline) with oral steroids. Oral steroids are the mainstay of medical management for patients with CRSwNP. However, recent studies have shown that doxycycline not only helps improve symptoms, but also reduces inflammation and kills common bacteria that can cause symptoms. This study is the first to evaluate this combination regimen.

Eligibility: patients should be older than 18 years of age and should not have cystic fibrosis, primary ciliary dyskinesia, or diabetes. An eligible patient may be treated with either doxycycline and oral steroids OR placebo (sugar pill) and oral steroids for three weeks. Volunteers will participate in the study for to 12 weeks, and will have 4 research visits of 1 hour duration. At each study visit, the patient will undergo an endoscopic evaluation and be asked to complete a questionnaire describing symptoms. There is no additional cost to be enrolled in the study. Those interested may contact the study coordinator, Neeraja Konuthula  or the principal investigator, Benjamin Malkin, MD, [GCO#14-0462, IRB approved through May 2016].

Chronic Sinusitis Steroid-Releasing Implant Trial: The Division offers a second multi-institutional clinical trial to evaluate the use of Intersect(tm) ENT's novel Propel steroid-releasing stent implant that is placed in the office setting for patients with chronic sinusitis and nasal obstruction due to nasal polyposis.

Eligibility: the Division is seeking adults with chronic sinusitis who have previously undergone bilateral total ethmoidectomy and are currently experiencing recurrent symptoms for a study investigating the use of steroid-releasing nasal implant. Patients should be older than 18 years of age and at least 90 days from surgery. Volunteers will participate in the study for up to 12 weeks, and will have 5 research visits of 1 to 2 hours duration. Activities include endoscopic evaluations, implant placement in the nasal cavity, and daily electronic diary entries. Those interested may contact the study coordinator, Neeraja Konuthula or the principal investigator, Alfred Marc Iloreta, MD.

Perioperative Outcomes: In conjunction with Department of Anesthesia, the Department of Otolaryngology’s Division of Rhinology, Sinus Surgery and Allergy sponsors several clinical trials to assess perioperative outcomes and to maximize patient comfort and safety in before and after the surgical procedures.

We offer a large scale cerebral-oximetry study during sinus endoscopy. This is a purely observational study, in which a novel device is used to measure the amount of oxygen flowing to the brain. The monitor will be covered at all times during the procedure, so it does not alter the care that the patient receives throughout the