CTRI/2024/02/062445招募中Unknown
A prospective, open label, multi-center, single-arm, observational post-market clinical follow-up registry study to evaluate the safety and performance of absorbable, oxidized regenerated cellulose hemostat - Surgi-ORC®. - NI
Aegis Lifesciences Pvt. Ltd.0 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
- 招募中
- 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. Used in all except those who are having known allergy to cellulose
- •2. Patient or their LDR is willing to sign Informed Consent Form (ICF)
- •3. Patients undergoing following surgeries: Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery.
- •4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up.
排除标准
- •1. Haemostat to be used for packing and wadding without removal after hemostasis is achieved.
- •2. Haemostat to be used for implantation in bone defects, such as fractures, which may interfere with callus formation and may cause cyst formation.
- •3. Removal of haemostat is not possible after achieving hemostasis in or around foramina in bone, areas of bony confine, the spinal cord or the optic nerve and chiasm.
- •4. Hemostasis is required for hemorrhage from large arteries.
- •5. Treatment non hemorrhagic serious oozing surfaces, since body fluids, except whole blood, such as serum, do not react with Surgi ORC Haemostat to give satisfactory result.
- •6. Haemostat is required as adhesion prevention product.
- •7. Patients with known hypersensitivity of Cellulose.
- •8. Hemostasis is required in open blood vessel.
- •9. Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
- •10. Patient has an active infection at the surgical site.
- •11. Patient has known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombobasthenia, haemophilia, or von Willebrand disease)
- •12. Patient has received antibiotic solutions or powders at the intended application site.
- •13. Patient is unavailable for follow-up.
- •14. Patient is currently participating in another clinical study.
研究者
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