N80-N98
Conditions
Interventions
Group 1: Women between 18 to 55 years age undergoing planned 3-Step therapy for endometriosis that includes GnRH- analogue administration and a second look laparoscopy (3- Step therapy: first laparosc
Sponsors
BioRegen Biomedical (Changzhou) Co., Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Women aged 18-55 Women willing, able to and having freely given written consent to participate in the study and abide its requirements. Women in good general health; including ASA (American Society of Anesthesiologists) score of 2 or less. - Women agree to a 3-step therapy for endometriosis - Subject not currently pregnant. Sexually active premenopausal women that agrees to not attempting pregnancy within 3 months after product application and agree to use a method of contraception.
Exclusion criteria
Exclusion criteria: Subjects that meet the main inclusion criteria but attempting to get pregnant within 3 months of product application. Patients must be also excluded if they meet any of the following criteria Current pregnancy including ectopic pregnancy. Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation. History of cancer within the past 5 years (excluding breast cancer) History of heparin induced thrombocytopenia (HIT), or known sensitivity to heparin-like products. History of blood coagulation disorders Active pelvic or abdominal infection. Additional surgical procedure (non-OB/GYN) planned to be performed during the laparoscopic procedure (excluding appendectomy) Known or suspected allergy to hyaluronic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, efficacy and manageability of BioRegen® crosslinked hyaluronic acid gel when used as a postoperative prophylactic anti-adhesion device in the reduction of post-surgical adhesions after endometriosis surgery. Enrollment takes place intraoperatively, presence of active severe and/ or extensive endometriosis and/ or related adhesions are confirmed at first laparoscopy. Photos from the endometriotic foci and adhesions at both laparoscopies will be taking. The ASRM-Adhesions score will be used to score the endometriosis and adhesions. Clinical signs of adverse events will be assessed and reported by the principal investigator (PI) in the CRF. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determinate the frequency of new peritoneal adhesions in the pelvic or abdominal cavity. - To determinate the frequency of re-formed peritoneal adhesions in the pelvic or abdominal cavity. - To evaluate the manageability of BioRegen crosslinked hyaluronic acid gel during application on peritoneal surfaces. - To determine the type and rate of complications. | — |
Countries
Germany
Contacts
Public ContactRudy Leon De Wilde
Pius-Hospital Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Outcome results
None listed