Evaluation of Orthoss® Collagen in generic indications of bone defect filing - OC Generic

Geistlich Pharma AG0 个研究点目标入组 66 人开始时间: 2022年3月25日最近更新: 2024年8月19日

适应症

试验速览

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•The patient (male or female) must be 18 years or older
•The patient must be a candidate for treatment of bone defects in aforementioned the indications
•If patient is of child-bearing potential, the patient confirms not to be pregnant
•The patient is able to comply with the clinical investigation -related procedures such as attending all follow-up procedures
•The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication
•The patient will not participate in another clinical investigation during this clinical investigation

•General contraindications for surgical treatment are present
•The patient has a history of malignancy, radiotherapy, or chemotherapy
•for malignancy within the past five years
•The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon
•The patient is pregnant or nursing
•Women of childbearing age who are not using a highly effective method of birth control
•The patient has acute or chronic infection at the surgical site
•The patient has a known allergy to collagen and/or bovine bone material
•The patient has a medical history of alcohol or drug abuse within the last
•year prior to the screening examination
•Vulnerable population
•Patient is currently participating, or has participated in another clinical investigation within 3 months

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