Objectives/hypothesis: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.
Study Design: Prospective individual cohort study.
Methods: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age.
Objectives: (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices.
Study Design: Prospective, multicenter, single arm.
Setting: Patients were recruited in 8 community-based practices in the United States between June and September 2017.
Int J Pediatr Otorhinolaryngol
December 2015
Objectives: Tympanostomy tube (tube) placement is the most common pediatric otolaryngologic surgery in the United States. Most surgeries are performed in an operating-room setting under general anesthesia due to the lack of tolerable and reliable local anesthesia methods suitable for pediatric patients, and concerns regarding myringotomy procedures in a mobile child. This study evaluated the safety and efficacy of an iontophoresis system (IPS) to achieve local anesthesia in combination with a tube delivery system (TDS) for tube placement in pediatric patients in an office setting.
View Article and Find Full Text PDFBackground: Treatment options for chronic rhinosinusitis with recurrent polyposis (CRSwNP) after endoscopic sinus surgery (ESS) are limited, and include frequent use of systemic steroids and revision surgery. A bioabsorbable, steroid-eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, controlled steroid delivery to reestablish sinus patency. This study assessed the initial feasibility, safety, and efficacy of steroid-eluting implants placed in the office setting in patients who were candidates for revision ESS.
View Article and Find Full Text PDFObjective: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) may be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent intervention. To address this issue, the authors investigated the safety and effectiveness of controlled delivery of mometasone furoate to the sinus mucosa via bioabsorbable implants deployed at the time of ESS.
Study Design: Prospective, multicenter, randomized, controlled, double-blind trial using an intrapatient control design.