CTRI/2024/06/068248尚未招募Unknown
A prospective, open label, multi-center, single-arm, observational post-market clinical follow-up study to evaluate the safety and performance of flowable gelatin haemostatic matrix kit in real-world patients. - NI
Aegis Lifesciences Private Limited0 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
- Unknown
- 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. A Patient requiring haemostasis in surgical procedures where
- •control of bleeding by standard surgical techniques is ineffective
- •or impractical.
- •2. A Patient or their legally designated guardian is willing to sign
- •Informed Consent Form (ICF)
- •3. A Patient willing to comply with the requirements given in ICF
- •including the requirements for participating till last follow-up.
- •4. All patients who are not allergic to gelatin.
排除标准
- •1. A Patient currently participating in another clinical study.
- •2. A Patient having known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombasthenia,
- •haemophilia, or Von Willebrand disease)
- •3. A Patient having allergy to porcine gelatin
- •4. A Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
- •5. A Patient undergoing ophthalmic surgery.
- •6. A Patient requiring closure of skin incisions by Flogel because it
- •may interfere with the healing of skin edges.
- •7. A Patient requiring haemostasis in intravascular compartments because of the risk of embolization.
- •8. A Patient requiring hemostasis in the absence of active blood flow e.g. while the vessel is clamped or bypassed as it may result
- •in risk of intravascular clotting from intravascular injection.
研究者
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