The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by:~Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval~Collecting all AEs and calculating an overall rate and safety profile for the device~The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.