Clinical trial NCT05747014: Novapak Prospective Observational Clinical Trial
Official title: Novapak Prospective Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Airway Obstruction
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the practices and clinics of the participating Study Investigators or from other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety Assessment - Adverse Events Related to Device
timeFrame: 30 days
measure: Safety Assessment - All Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment
timeFrame: 30 days
measure: Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment
timeFrame: 30 days
measure: Effectiveness Assessment - Bleeding Control
timeFrame: 1 day
measure: Effectiveness Assessment - Healing
timeFrame: 30 day
measure: Effectiveness Assessment - Health Assessment
timeFrame: 30 day
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: London
country: Canada
facility: St. Joseph's Health Care
state: Onterio
Study officials:
affiliation: Medtronic
name: Karen R McKenzie, MS
role: STUDY_DIRECTOR
References: