Adhesion prevention with 4DryField® PH in hysteroscopic surgery

Not Applicable

Recruiting

• Conditions: D25; N85.6; Q51.9; Leiomyoma of uterus; Intrauterine synechiae; Congenital malformation of uterus and cervix, unspecified

• Registration Number: DRKS00031857
• Lead Sponsor: PlantTec Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 118

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
-Individual evaluation of subcategories of primary endpoint<br>-Pregnancy rate (in the subgroup of patients wishing to conceive)<br>-Frequency of re-interventions for adhesiolysis<br>-Dysmenorrhea<br>-If and when normal cycle reoccurs<br>-Rate of complications