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Completed

NCT Number: NCT05747014

Novapak Prospective Observational Clinical Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Health Care, London, Onterio, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Safety Assessment - Adverse Events Related to Device

    Time frame: 30 days

    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.

  2. Safety Assessment - All Adverse Events

    Time frame: 30 days

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

Secondary outcomes

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

    Time frame: 30 days

    Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions observed by endoscopic examination from procedure through 1-month post treatment.

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

    Time frame: 30 days

    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), where '0' is No Adhesion Present, and '3' is >50% of middle turbinate height. This scoring is the Valentine method, and participants are graded based on their endoscopic examination.

  3. Effectiveness Assessment - Bleeding Control

    Time frame: 1 day

    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. The Boezaart scale grades bleeding from Grade 0: No Bleeding through Grade 5: Severe Bleeding.

  4. Effectiveness Assessment - Healing

    Time frame: 30 day

    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. The Lund-Kennedy Scoring minimum is 0 and maximum is 10, with higher scores indicating worse observed disease. The Lund-Kennedy grading system is as follows:

    Nasal Polyps 0 = none; 1 = confined to middle meatus; 2 = beyond middle meatus Discharge 0 = none; 1 = clear and thin; 2 = thick and purulent Edema 0 = absent; 1 = mild; 2 = severe Scarring 0 = absent; 1 = mild; 2 = severe Crusting 0 = absent; 1 = mild; 2 = severe Numerical values for each term are summed for each sinus analyzed; and mean averages are reported.

  5. Effectiveness Assessment - Health Assessment

    Time frame: 30 day

    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. The Sino-Nasal Outcome Test (SNOT-22) is a validated questionnaire used to assess the severity of 22 symptoms related to the nasal sinuses using a 0-5-point scale (0 = No problem; 1 = Very mild problem; 2 = Mild or slight problem; 4 = Moderate problem; 5 = Problem as bad as it can be). Minimum score: 0; Maximum score: 110. The higher the score the worse the problems are.

Sponsors and collaborators

Lead sponsor

Medtronic Surgical Technologies

Industry

Registry information

Acronym: Novapak

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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