A Prospective, Multi-center, Single Arm Post-market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of ENTACT™ (Next Generation) Resorbable Septal Staple System for Septoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit
研究概览
简要总结
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in Europe (data may be used to support registrations on other countries as well).
详细描述
The primary objective of this study is to demonstrate clinical success of the ENTACT (Next Generation) resorbable septal staple system by examining the patient's nasal cavity at the 21 day follow-up visit.
The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient will be eligible for the study if he or she meets all of the following inclusion criteria at the baseline screening:
- •Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB);
- •Clinically significant deviation of the nasal septum;
- •Willing and able to make all required study visits;
- •Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)
排除标准
- •The patient will be ineligible for the study if he or she meets any of the following exclusion criteria at the baseline screening or during surgery:
- •Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
- •Traditional suturing techniques are necessary;
- •Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
- •Known to be allergic to foreign body of materials of investigational product;
- •Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
- •Pregnancy at time of procedure;
- •Presence of infection at the site;
- •Severe drug and alcohol abusers;
- •Autoimmune disease deemed clinically significant by Principal Investigator (PI).
结局指标
主要结局
Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit
时间窗: 21 days
At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were "YES" then clinical success was inferred (if any answer was "NO" then repair failure was inferred).
次要结局
- Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)(Day: 5, 21, and 42)
- Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)(Day: 5, 21, and 42)
- Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)(Day: 5, 21, and 42)
- Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)(Day: 5, 21, and 42)
- Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits(Day: 0 (Screening), 5, 21 and 42)
- Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)(Day: 5, 21, and 42)
- Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits(Day: 0 (Screening), 5, 21 and 42)
- Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations(During procedure, up to 306 seconds)
- Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations(During procedure, up to 97 minutes)