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相关临床试验
9
4 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
2002
进行中（未招募）
3
33.3%
已完成
4
44.4%
Enrolling By Invitation
1
11.1%
暂停
暂无批准数据
- Integra LifeSciences has enrolled the first patient in the Acclarent AERA Pediatric Registry, a prospective multi-center observational study evaluating real-world use of the AERA Eustachian Tube Balloon Dilation System in children. - The registry aims to capture safety and efficacy outcomes for up to 300 pediatric patients with obstructive Eustachian tube dysfunction across up to 20 U.S. sites. - Primary endpoint focuses on failure-free status following balloon dilation, with failure defined as need for revision surgery including additional procedures or tube placement. - The study will generate real-world evidence to support broader clinical adoption and improve reimbursement pathways for pediatric Eustachian tube balloon dilation procedures.
