Monocentric, single-arm, confirmatory, prospective, non-controlled study to assess the safety and performance of a non-cross-linked sodium hyaluronate (HA) gel as surgical adhesion barrier in patients with suspected endometriosis indicated for a second look surgery

Not Applicable

• Conditions: Suspected deep infiltrating endometriosis; N80; Endometriosis

• Registration Number: DRKS00023266
• Lead Sponsor: S&V Technologies GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study Completion: 2022-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 136

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>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.