Trial Outcomes & Findings for Novapak Prospective Observational Clinical Trial (NCT NCT05747014)

NCT ID: NCT05747014

Last Updated: 2024-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 86 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	Novapak Subjects Subjects that are enrolled in the Novapak Study. 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.
Enrollment STARTED	86
Enrollment COMPLETED	77
Enrollment NOT COMPLETED	9
14-Day Follow-up STARTED	77
14-Day Follow-up COMPLETED	76
14-Day Follow-up NOT COMPLETED	1
30-Day Follow-up STARTED	76
30-Day Follow-up COMPLETED	74
30-Day Follow-up NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race was not collected for Canadian site. Only US sites were able to report race (n=57).

Baseline characteristics by cohort

Measure	Novapak Subjects n=86 Participants Subjects that are enrolled in the Novapak Study. 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.
Age, Continuous	48.62 years STANDARD_DEVIATION 17.36 • n=86 Participants
Sex: Female, Male Female	42 Participants n=86 Participants
Sex: Female, Male Male	44 Participants n=86 Participants
Race/Ethnicity, Customized RACE · WHITE	40 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · LATIN AMERICAN	4 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · NOT REPORTED	2 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · WHITE CARIBBEAN	2 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · AFRICAN AMERICAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · ARAB	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · ASIAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · ASIAN INDIAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · BAHAMIAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · BLACK OR AFRICAN AMERICAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · MEDITERRANEAN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · MIDDLE EASTERN	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Race/Ethnicity, Customized RACE · OTHER	1 Participants n=57 Participants • Race was not collected for Canadian site. Only US sites were able to report race (n=57).
Region of Enrollment Canada	29 participants n=86 Participants
Region of Enrollment United States	57 participants n=86 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=62 Adverse Events Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up Lund-Kennedy Score at 30-day follow-up
Safety Assessment - Adverse Events Related to Device Device Relatedness - Causal Relationship	0 Adverse Events	—	—
Safety Assessment - Adverse Events Related to Device Device Relatedness - Probable	1 Adverse Events	—	—
Safety Assessment - Adverse Events Related to Device Device Relatedness - Possible	2 Adverse Events	—	—
Safety Assessment - Adverse Events Related to Device Device Relatedness - Not Related	59 Adverse Events	—	—

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=77 Participants Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up Lund-Kennedy Score at 30-day follow-up
Safety Assessment - All Adverse Events	62 Adverse Events	—	—

SECONDARY outcome

Timeframe: 30 days

Population: This outcome was analyzed by sinus not by subject

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

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=138 Sinuses Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up n=132 Sinuses Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up Lund-Kennedy Score at 30-day follow-up
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment	6 Sinuses	5 Sinuses	—

SECONDARY outcome

Timeframe: 30 days

Population: For this outcome, analysis was done by sinus not by subject

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.

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=138 Sinuses Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up n=132 Sinuses Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up Lund-Kennedy Score at 30-day follow-up
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment NO ADHESION PRESENT	132 Sinuses	127 Sinuses	—
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment < 25% OF MIDDLE TURBINATE HEIGHT	5 Sinuses	4 Sinuses	—
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment BETWEEN 25 AND 50% OF MIDDLE TURBINATE HEIGHT	0 Sinuses	1 Sinuses	—
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment >50% OF MIDDLE TURBINATE HEIGHT	1 Sinuses	0 Sinuses	—

SECONDARY outcome

Timeframe: 1 day

Population: For this outcome, analysis was done by sinus, not by subject

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.

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=139 Sinuses Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up n=139 Sinuses Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up Lund-Kennedy Score at 30-day follow-up
Effectiveness Assessment - Bleeding Control GRADE 0: NO BLEEDING (CADAVERIC CONDITIONS)	8 Sinuses	86 Sinuses	—
Effectiveness Assessment - Bleeding Control GRADE 1: SLIGHT BLEEDING - NO SUCTIONING REQUIRED	76 Sinuses	53 Sinuses	—
Effectiveness Assessment - Bleeding Control GRADE 2: SLIGHT BLEEDING - OCCASIONAL SUCTIONING REQUIRED	29 Sinuses	0 Sinuses	—
Effectiveness Assessment - Bleeding Control GRADE 3: SLIGHT BLEEDING - FREQUENT SUCTIONING REQUIRED; BLEEDING THREATENS SURGICAL FIELD A FEW ...	23 Sinuses	0 Sinuses	—
Effectiveness Assessment - Bleeding Control GRADE 4: MODERATE BLEEDING - FREQUENT SUCTIONING REQUIRED AND BLEEDING THREATENS SURGICAL FIELD D...	3 Sinuses	0 Sinuses	—
Effectiveness Assessment - Bleeding Control GRADE 5: SEVERE BLEEDING - CONSTANT SUCTIONING REQUIRED; BLEEDING APPEARS FASTER THAN CAN BE REMO...	0 Sinuses	0 Sinuses	—

SECONDARY outcome

Timeframe: 30 day

Population: For this outcome, analysis was done by sinus not by subject

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.

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=139 Sinuses Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up n=138 Sinuses Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up n=132 Sinuses Lund-Kennedy Score at 30-day follow-up
Effectiveness Assessment - Healing	3.27 score on a scale Standard Deviation 1.95	1.99 score on a scale Standard Deviation 1.28	1.09 score on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 30 day

Population: The analysis population is number of subjects that completed the SNOT-22 questionnaire at each timepoint.

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.

Outcome measures

Measure	Total Number of Adverse Events Directly Attributed to the Device and/or Cannot be Determined n=79 Participants Total number of adverse events recorded that are attributed to the device or could not be determined. 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.	30-Day Follow-up n=75 Participants Subjects that are enrolled in the Novapak Study and have completed their 30-day follow-up visit.	30-Day Follow-up n=72 Participants Lund-Kennedy Score at 30-day follow-up
Effectiveness Assessment - Health Assessment	40.59 score on a scale Standard Deviation 18.05	25.03 score on a scale Standard Deviation 18.83	18.67 score on a scale Standard Deviation 16.80

Adverse Events

Novapak Subjects

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Novapak Subjects n=77 participants at risk 86 total subjects were enrolled in the Novapak Study with 0 reported deaths. 77 subjects were implanted with the Novapak device and underwent Adverse Event Assessment(s). 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.
Injury, poisoning and procedural complications Scar	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.

Other adverse events

Measure	Novapak Subjects n=77 participants at risk 86 total subjects were enrolled in the Novapak Study with 0 reported deaths. 77 subjects were implanted with the Novapak device and underwent Adverse Event Assessment(s). 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.
Gastrointestinal disorders Abdominal pain upper	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
General disorders Adverse drug reaction	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Eye disorders Blindness unilateral	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Infections and infestations COVID-19	2.6% 2/77 • Number of events 2 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.2% 4/77 • Number of events 6 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Eye disorders Eye disorder	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
General disorders Facial discomfort	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
General disorders Facial pain	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Nervous system disorders Headache	6.5% 5/77 • Number of events 5 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Gastrointestinal disorders Hyperaesthesia teeth	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Nervous system disorders Hyposmia	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.6% 2/77 • Number of events 2 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Nasal crusting	6.5% 5/77 • Number of events 5 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Nasal oedema	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Infections and infestations Nasopharyngitis	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Gastrointestinal disorders Nausea	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Eye disorders Ocular discomfort	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Paranasal sinus inflammation	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Eye disorders Periorbital oedema	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Injury, poisoning and procedural complications Post procedural fever	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Injury, poisoning and procedural complications Post procedural haemorrhage	2.6% 2/77 • Number of events 2 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Injury, poisoning and procedural complications Procedural pain	2.6% 2/77 • Number of events 2 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Rhinalgia	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.9% 3/77 • Number of events 4 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Skin and subcutaneous tissue disorders Scab	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Nervous system disorders Sensory loss	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Infections and infestations Sinusitis	3.9% 3/77 • Number of events 3 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Infections and infestations Sinusitis bacterial	7.8% 6/77 • Number of events 6 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Skin and subcutaneous tissue disorders Skin burning sensation	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.
Gastrointestinal disorders Vomiting	1.3% 1/77 • Number of events 1 • Adverse events were collected from procedure through 30-day follow-up. All adverse events that occurred from procedure through each subject's 30-day follow-up visit were collected.

Additional Information

Rianna Rapson - Clinical Study Manager

Medtronic

Phone: 763-526-2170

Email: rianna.k.rapson@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee PIs may publish as long as publications are provided to Medtronic for review at least 60 days prior to submission or presentation. Additionally, PIs will not independently publish, publicly disclose, present or discuss any Study results until a multi-center publication is released. If a multi-center publication is not released within one year after completion PIs will have the right to publish the results of and information pertaining to their activities on the Study.
• Publication restrictions are in place

Restriction type: OTHER