NCT07796165尚未招募不适用
SNIP 2 Case Series
Europa Life Sciences Limited1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年10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
- 尚未招募
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Clinician Device Experience
研究概览
简要总结
Case series of infants with anterior ankyloglossia being treated by the Sublingual Neonatal Incision Platform device
详细描述
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankyloglossia requiring intervention
排除标准
- •Concomitant morphological variation in the oral cavity which could compromise frenotomy
- •Blood dyscrasia
- •Immunocompromise
研究组 & 干预措施
Non-treatment
No Intervention
Patient identified as not requiring frenotomy
Infant with ankyloglossia requiring intervention
Experimental
Patient is treated using the novel device
干预措施: Frenectomy of anterior ankylogossia using the novel device (Device)
结局指标
主要结局
Clinician Device Experience
时间窗: Immediately post-op
The physician will be asked to rate following attributes of the use of the tool, in Likert scale of 1-5; Whether the device felt intuitive, whether they felt more confident using this device, whether they would use this device again for a similar release?
次要结局
- Operator-perceived infant discomfort(Immediately post-op)
研究者
研究点 (1)
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