A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier following Hysteroscopic Adhesiolysis - INN-CG-001

Innocoll Technologies0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

试验速览

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•- Be a female >=18 and <= 45 years of age
•- Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
•- Willing to use additional contraception until the study is completed
•- Understand and be willing to follow all aspects of the study protocol and is able to provide written Informed Consent prior to any study-related procedures being performed

•- Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
•- Be a female of childbearing potential not using a reliable means of contraception
•- Has suffered or currently suffers from a gynaecological malignancy
•- Has a current genital infection
•- Has a known or suspected hypersensitivity to collagen
•- Has a known or suspected increased risk of infections (due to e.g. (auto)immune diseases or taking medications influencing infection risk)
•- Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
•- Has a condition or be in a situation that, in the Investigator*s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject*s participation in the study
•- No adhesion formation present in the uterus
•- Severe adhesion formation which cannot be removed in one procedure
•- Has a condition or be in a situation which could only be determined during the hysteroscopic procedure that, in the Investigator*s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject*s participation in the study

发起方

Innocoll Technologies