Suspected deep infiltrating endometriosis N80
Conditions
Interventions
Group 1: ADSV is applied during first laparoscopy primarily in the area of resected tissue, which was resected with the aim to confirm the diagnosis of an endometriosis histologically. If other adhesi
Sponsors
S&V Technologies GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Preoperative - Suspicion of deep infiltrating endometriosis (DIE) - Indication for laparoscopic surgery to confirm the diagnosis endometriosis and the physical and mental condition to undergo the surgery - Willing, able to and having freely given written consent for participation in the study Intraoperative - Indication for a second look surgery due to the extent of endometriosis (assessed by the surgeon)
Exclusion criteria
Exclusion criteria: Preoperative - abdominal surgery due to oncological disease or other diseases - pregnant, lactating - participation in another clinical investigation or participation in another interventional investigation or study within the last 30 days - known or suspected allergy or intolerance to the investigational device (e.g. Sodium Hyaluronate) - known history of severe multiple drug allergies - active infections / intra-abdominal infections such as peritonitis, abdominal abscess, anastomotic leakage or fistula - follow-up impossible for social, geographical, familial or psychological reasons - auto-immune disease or during immunotherapy - coagulation disorders deemed by the surgeon to interfere with wound healing - planned chemotherapy before or after abdominal surgery - life expectancy of less than 6 months because of a medical condition or disease state - received systemic agents with the intention to prevent adhesion formation within 30 days prior to the index procedure or plan to receive it within the study period - cancer requiring chemotherapy and/or radiotherapy within 30 days prior to the initial surgery or between the initial surgery and the second look surgery - clinically significant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease which would interfere with the study or jeopardize patient outcomes - kidney dysfunction or kidney disease - simultaneous treatment with systemic corticosteroids, antineoplastic agents and/or radiotherapy (e.g. X-ray) - drug or alcohol addiction Intraoperative - intraoperative assessment of cancer - need for treatment with fibrin glue, surgical sealant or other hemostatic agents - need for open surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the successful adhesion prevention of the HA installation assessed quantitatively by the outcome of the second look laparoscopy, when no de novo formed adhesion is found (yes/no). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are the safety of ADSV, the specific performance of the device and the effect on the patient’s quality of life and pain. Specifically, the assessed safety endpoints are AEs/SAEs, vital signs (body temperature, blood pressure, pulse, breathing rate), and wound healing. Assessed performance endpoints are severity of adhesion, surgeon's satisfaction with the device and its application, pain, and quality of life. | — |
Countries
Germany
Contacts
Public ContactBernhard Krämer
University Hospital Tübingen - Department of Women’s Health
Outcome results
None listed