Novapak Prospective Observational Clinical Trial (Novapak)

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 Overview

• Status: Completed
• Conditions: Nasal Airway Obstruction
• Intervention / Treatment: Device: Novapak Nasal Sinus Packing and Stent

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

• Study Contact: Name: Rianna Rapson; Phone Number: 612-526-2170; Email: rianna.k.rapson@medtronic.com
• Study Contact Backup: Name: David Hodge; Phone Number: 904-281-2774; Email: david.l.hodge@medtronic.com

Study Locations

• Canada
  • Onterio
    • London, Onterio, Canada, N6A 4V2
      • St. Joseph's Health Care
• United States
  • Florida
    • Boca Raton, Florida, United States, 33487
      • ENT Associates of South Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Tampa, Florida, United States, 33612
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the practices and clinics of the participating Study Investigators or from other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Novapak Subjects; Subjects that are enrolled in the Novapak Study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Novapak Safety Assessment	Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined.	30 days
Novapak Safety Assessment	Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Novapak Effectiveness Assessment	Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions from procedure through 1-month post treatment.	30 days
Novapak Effectiveness Assessment	Outcome Measure #4 for the Secondary Outcome Measures is the graded percentage of vertical height of the middle turbinate taken up by the adhesion using an ordinal scale (0-3) from procedure through 1-month post treatment.	30 days
Novapak Effectiveness Assessment	Outcome Measure #5 for the Secondary Outcome Measures is to measure control of bleeding by comparing Boezaart Surgical Field Grading Scale scores post operatively, prior to Novapak insertion and post Novapak insertion.	1 day
Novapak Effectiveness Assessment	Outcome Measure #6 for the Secondary Outcome Measures is to measure healing by comparing Lund-Kennedy scores before surgery and at 2 weeks and 1-month post treatment.	30 day
Novapak Effectiveness Assessment	Outcome Measure #7 for the Secondary Outcome Measures is to measure health by comparing subject scores from the SNOT-22 questionnaire before surgery and at 2 weeks and 1-month post treatment.	30 day

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Study Director: Karen R McKenzie, MS, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: MDT 22031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No