CTRI/2026/07/113930进行中（未招募）不适用
A Prospective Open-Label Study to Evaluate the Safety and Performance of SERIBO SYSTEMS CMF Bone Plates and Screws in Craniomaxillofacial surgeries - NIL
OsteoForge MedTech Private Limited0 个研究点目标入组 12 人开始时间: 2026年8月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants aged 06 years to 65 years
- •Those who voluntarily agreed to participate in clinical trials and were willing to comply with the study protocol
- •Participants with any one of the following
- •Minimally displaced and undisplaced cranial fractures
- •Minimally displaced and undisplaced maxillary fractures
- •Minimally displaced and undisplaced Zygomaticomaxillary fractures
- •Minimally displaced and undisplaced mandible fractures
排除标准
- •Complex and comminuted Cranial fractures
- •Complex and comminuted maxillary displaced fractures
- •Complex and comminuted zygomaticomaxillary fractures
- •Complex and comminuted mandibular fractures
- •Unfavorable fractures
- •Participants with uncontrolled metabolic diseases
- •Participants with heart disease or liver dysfunction
- •Participants with blood disease
- •Participants who cannot stop taking steroids, anti-thrombotic, or anticoagulants before surgery
- •Drug abusers, alcoholics and Smokers
- •Women who are pregnant, breast feeding or have a pregnancy plan during the clinical trial period.
- •Investigator judges that participation in the clinical trial is inappropriate due to safety concerns or other medical reasons.
研究者
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