Novapak Prospective Observational Clinical Trial

Last updated: September 19, 2024
Sponsor: Medtronic Surgical Technologies
Overall Status: Completed

Phase

N/A

Condition

Acute Rhinitis

Nasal Obstruction

Bronchiectasis

Treatment

Novapak Nasal Sinus Packing and Stent

Clinical Study ID

NCT05747014
MDT 22031
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is at least 18 years of age.

  2. Subject undergoing nasal/sinus surgery with the intended need for nasal sinuspacking (i.e., Novapak).

  3. After being informed of the nature of the study; the subject understands, agrees toits provisions, is willing to participate and provide written consent.

  4. Mentally stable and able to follow the instructions forself-assessment/questionnaire completion.

Exclusion

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 thesinuses.

  4. Subject is immunocompromised (e.g., taking immunosuppressive medication).

  5. Subject is participating in another investigational device, biologic, or drug studyand has not completed the primary endpoint(s) or if there is a potential forclinical interference beyond the primary endpoint.

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: Novapak Nasal Sinus Packing and Stent
Phase:
Study Start date:
March 09, 2023
Estimated Completion Date:
December 13, 2023

Study 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.

Connect with a study center

  • St. Joseph's Health Care

    London, Onterio N6A 4V2
    Canada

    Site Not Available

  • ENT Associates of South Florida

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

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