Novapak Prospective Observational Clinical Trial

Completed

Conditions: Nasal Airway Obstruction

Interventions: Device: Novapak Nasal Sinus Packing and Stent

Registration Number: NCT05747014

Lead Sponsor: Medtronic Surgical Technologies

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novapak Subjects	Novapak Nasal Sinus Packing and Stent	Subjects that are enrolled in the Novapak Study.

Primary Outcome Measures

Name	Time	Method
Safety Assessment - Adverse Events Related to Device	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.
Safety Assessment - All Adverse Events	30 days	Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.

Secondary Outcome Measures

Name	Time	Method
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment	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.
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment	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.
Effectiveness Assessment - Bleeding Control	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.
Effectiveness Assessment - Healing	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.
Effectiveness Assessment - Health Assessment	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.

Trial Locations

Locations (4): ENT Associates of South Florida
🇺🇸
Boca Raton, Florida, United States
St. Joseph's Health Care
🇨🇦
London, Onterio, Canada
University of South Florida
🇺🇸
Tampa, Florida, United States
University of Miami
🇺🇸
Miami, Florida, United States