Novapak Prospective Observational Clinical Trial

NCT05747014 | Completed Results FDA Device

• 1 other identifier: MDT 22031
• Study Type: observational
• Target: 86
• Locations: 2 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety Assessment - Adverse Events Related to Device

  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

• Safety Assessment - All Adverse Events

  Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.

  30 days

Secondary Outcomes (5)

• Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment

  30 days

• Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment

  30 days

• Effectiveness Assessment - Bleeding Control

  1 day

• Effectiveness Assessment - Healing

  30 day

• Effectiveness Assessment - Health Assessment

  30 day

Study Arms (1)

Novapak Subjects

Subjects that are enrolled in the Novapak Study.

Device: Novapak Nasal Sinus Packing and Stent

Interventions

Novapak Nasal Sinus Packing and Stent DEVICE

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

Novapak Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subject has a shellfish allergy.
• Subject has known bleeding disorder or prescribed anticoagulants.
• Subject has craniofacial abnormalities that may interfere with access to the sinuses.
• Subject is immunocompromised (e.g., taking immunosuppressive medication).
• 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.

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (4)

ENT Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

St. Joseph's Health Care

London, Onterio, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Stents

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Rianna Rapson - Clinical Study Manager
• Organization: Medtronic

rianna.k.rapson@medtronic.com

763-526-2170

Study Officials

• Karen R McKenzie, MS

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 28, 2023
• Study Start: March 9, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)