Novapak Prospective Observational Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Safety Assessment - Adverse Events Related to Device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Safety Assessment - Adverse Events Related to Device
时间窗: 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
时间窗: 30 days
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
次要结局
- Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment(30 days)
- Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment(30 days)
- Effectiveness Assessment - Bleeding Control(1 day)
- Effectiveness Assessment - Healing(30 day)
- Effectiveness Assessment - Health Assessment(30 day)