N/A
Completed N=86
Novapak Prospective Observational Clinical Trial
Nasal Airway Obstruction
Source: ClinicalTrials.gov NCT05747014 ↗
Enrolled (actual)
86
Serious AEs
2.6%
Results posted
Nov 2024
Primary outcomePrimary: Safety Assessment - Adverse Events Related to Device — 0; 1; 2; 59 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessment - Adverse Events Related to Device |
0; 1; 2; 59 | — |
| PRIMARY Safety Assessment - All Adverse Events |
62 | — |
| SECONDARY Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment |
6; 5 | — |
| SECONDARY Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment |
132; 127; 5; 4; 0; 1 | — |
| SECONDARY Effectiveness Assessment - Bleeding Control |
8; 86; 76; 53; 29; 0 | — |
| SECONDARY Effectiveness Assessment - Healing |
3.27; 1.99; 1.09 | — |
| SECONDARY Effectiveness Assessment - Health Assessment |
40.59; 25.03; 18.67 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05747014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.