Novapak Prospective Observational Clinical Trial

Nasal Airway Obstruction Clinical Trial

— Novapak  

Official title:

Novapak Prospective Observational Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747014
• Other study ID #: MDT 22031
• Status: Completed
• Start date: March 9, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: March 2024
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Airway Obstruction
• Nasal Obstruction

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Onterio
United States	ENT Associates of South Florida	Boca Raton	Florida
United States	University of Miami	Miami	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Novapak Safety Assessment	Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.	30 days
Secondary	Novapak Effectiveness Assessment	Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions from procedure through 1-month post treatment.	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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