XprESS Eustachian Tube Balloon Dilation Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 11
- 主要终点
- Complication rate
研究概览
简要总结
A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
详细描述
This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.
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
- 否
入选标准
- •Be at least 18 years old
- •Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
- •Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
- •Be able to read and understand English
- •Be willing and able to provide informed consent
- •Be willing to comply with the protocol requirements
排除标准
- •Have a history of patulous Eustachian tube
- •Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
- •Have evidence of internal carotid artery dehiscence
- •Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
结局指标
主要结局
Complication rate
时间窗: 6 Months
Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.
Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score
时间窗: 6 Months
Change from baseline to follow-up in the mean overall ETDQ-7 score. The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.
次要结局
- Procedural information(Procedure through 6-week follow-up)
- Improvement in ability to perform a Valsalva maneuver(6 Months)
- Minimal clinically important difference in ETDQ-7 score(6 Months)
- Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family(6 Months)
- Change in work productivity/activity impairment(6 Months)
- Change from baseline in chronic rhinosinusitis symptoms(6 Months)
- Revision Eustachian tube dilation(6 Months)
- Surgical interventions(6 Months)
- Improvement in tympanogram(6 Months)
- Improvement in tympanic membrane position(6 Months)