D25 N85.6 Q51.9
Conditions
Interventions
Group 1: Adhesion prevention is performed using 4DryField® PH. The investigational device 4DryField® PH will be applied surgically invasive. The application will be carried out at the end of the inter
Sponsors
PlantTec Medical GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hysteroscopic surgery for treatment of intrauterine lesions (septa, myoma, adhesions) with second look hysteroscopy 2. Written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding period 2. menopause (FSH>40 mIU/ml, 17ß-estradiol<20pg/ml) 3. Malignant tumor of the reproductive organs 4. coagulopathy or a systemic illness that might cause coagulopathy 5. Refusal of follow-up hysteroscopy 6. Expected poor compliance of the patient or patient's inability to understand the purpose of the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the adhesion score at second look hysteroscopy. For this purpose, the establish classification system for intrauterine adhesions published by the American Fertility Society (AFS) will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Individual evaluation of subcategories of primary endpoint - Pregnancy rate (in the subgroup of patients wishing to conceive) - Frequency of re-interventions for adhesiolysis - Dysmenorrhea - If and when normal cycle reoccurs - Rate of complications - SF36 Questionnaire - Menorrhagia Impact Questionnaire | — |
Countries
Germany
Contacts
Public ContactFelix Neis
Universitätsklinikum Tübingen, Department für Frauengesundheit
Outcome results
None listed