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Novapak Prospective Observational Clinical Trial | Clinical Trials | Clareo Health

COMPLETED

Novapak Prospective Observational Clinical Trial

NCT05747014•Medtronic Surgical Technologies

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is at least 18 years of age.
•2. Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak).
•3. After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent.
•4. Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.

Exclusion Criteria

•1. Subject has a shellfish allergy.
•2. Subject has known bleeding disorder or prescribed anticoagulants.
•3. Subject has craniofacial abnormalities that may interfere with access to the sinuses.
•4. Subject is immunocompromised (e.g., taking immunosuppressive medication).
•5. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.

Locations (4)

ENT Associates of South Florida

Boca Raton, Florida, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

St. Joseph's Health Care

London, Onterio, Canada

Key Dates

Start Date

March 9, 2023

Primary Completion Date

December 13, 2023

Completion Date

December 13, 2023

Last Updated

November 21, 2024

Enrollment

ACTUAL participants

Conditions

Nasal Airway Obstruction

Interventions

Novapak Nasal Sinus Packing and Stent

DEVICE