NCT02228720已完成不适用
The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency
Intersect ENT4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Device Placement Success Rate
研究概览
简要总结
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.
详细描述
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years of age.
- •Patient is willing and able to comply with protocol requirements.
- •Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
- •Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both).
- •Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting.
- •Patient has nasal polyps no greater than grade
- •Patient with nasal polyps greater than 2 are eligible after their reduction/removal during ESS without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician.
- •Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
- •Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.
- •CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
- •Patient has a minimum total CT stage (Lund-Mackay method) of
- •Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan.
- •Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. In the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created.
- •Technique used for frontal or maxillary sinus surgery was the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
- •Septoplasty for access to the ostio-meatal complex is permitted.
排除标准
- •Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement.
- •Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement.
- •Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV).
- •Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
- •Patient has oral-steroid dependent condition such as COPD, asthma or other condition.
- •Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.
- •Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.).
- •Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue, etc.).
- •Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period.
- •Patient is currently participating in another clinical trial.
- •Patient has history of insulin dependent diabetes mellitus.
- •Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
- •Patient has known dehiscence of the lamina papyracea.
- •Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles).
- •Significant complication during the current peripheral ostia surgery/such as excessive blood loss, CSF leak or punctured lamina papyracea.
- •Current surgical intervention (operating room or office setting) is aborted for any reason.
研究组 & 干预措施
Propel Nova Sinus Implant
Experimental
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
干预措施: Propel Nova Sinus Implant (Device)
结局指标
主要结局
Device Placement Success Rate
时间窗: Baseline Procedure
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
次要结局
- Degree of Inflammation(Baseline, Day 30, Day 90)
- Sino-Nasal Outcome Test (SNOT) 22(Baseline, Day 30, Day 90)
- Ostial Patency(Baseline, Day 30, Day 90)
- Adhesion/Scarring Grade 2 & 3(Baseline, Day 30, Day 90)
研究者
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)Sickle Cell DiseaseHemoglobinopathiesNCT04853576Editas Medicine, Inc.45
已完成
不适用
SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval StudySymptomatic Cervical Disc DiseaseNCT00882661Globus Medical Inc380
Unknown
不适用
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary TuberculosisPulmonary TuberculosisNCT05359315SPP Pharmaclon Ltd.84
已完成
不适用
A clinical feasibility study to evaluate the effectiviness and safety of VivescOs TM as bone graft for reconstruction of intra-oral osseous defects.NL-OMON24005Isotis, Bilthoven, the Netherlands10
已完成
不适用
Electronic Intervention for HIV Medication AdherenceHIVNCT01291485Oklahoma State University Center for Health Sciences97