adherence of internal walls of the uterus intrauterine adhesions (IUA)
Conditions
Interventions
None listed
Sponsors
Innocoll Technologies
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Be a female >=18 and
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this clinical investigation is to determine the usability of the use of CollaGUARD in hysteroscopic adhesiolysis. Safety shall be assessed by means of recording serious adverse events. The safety endpoint of this trial is freedom from unexpected serious device related adverse events during the complete study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this clinical investigation are: - The number of de novo adhesions and adhesion reformations - Change in severity of the adhesions based on the ESGE and mAFS IUA classification scale at all follow-up visits - Product positioning and degradation level at each follow-up visit | — |
Countries
Netherlands
Outcome results
None listed