CTRI/2024/07/070241尚未招募4 期
A Prospective, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance ofCraniomaxillofacial Plate System - NI
Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or Female, aged 18 - 75 years.
- •2. Patients presenting emergency/OPD requiring fixation of CMF fracture.
排除标准
- •1. Subjects with a disease entity or condition that could hinder bone healing
- •and create unacceptable risk of fixation failure or complications such as
- •known active cancer, neuromuscular disorder.
- •2. Subjects with metabolic bone disease.
- •3. Subject with inadequate tissue coverage of the operative site.
- •4. Subjects with substance abuse/alcoholics.
- •5. Subjects who are incarcerated or have pending incarceration.
- •6. Female participant who is pregnant or planning pregnancy during the
- •7. Morbid obesity.
研究者
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