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Novapak Prospective Observational Clinical Trial

NCT05747014 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2024-11-21

Study results available
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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.

Conditions

  • Nasal Airway Obstruction

Interventions

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.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Karen R McKenzie, MS · Medtronic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747014 on ClinicalTrials.gov