CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Novapak Nasal Sinus Packing and Stentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05747014
NCT05747014N/ACompleted
CompareCT.gov

Novapak Prospective Observational Clinical Trial

Medtronic Surgical Technologies·observational·Posted Feb 28, 2023·Updated Nov 21, 2024

In Brief

An observational study evaluating Novapak Nasal Sinus Packing and Stent for Nasal Airway Obstruction. Completed, enrolled 86 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Airway Obstruction
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedFeb 28, 2023
Enrollment StartMar 9, 2023
Primary CompletionDec 13, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.3 years ago

Interventions

Novapak Nasal Sinus Packing and Stentdevice

Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations.