NCT05747014

Novapak Prospective Observational Clinical Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Nasal Airway Obstruction

Interventions

Type	Name	Description
DEVICE	Novapak Nasal Sinus Packing and Stent	Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations.

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2023-02-28
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study