Assessment of the antiadhesion efficacy of BioRegen® crosslinked hyaluronic acid gel in Laparoscopically Endometriosis Surgery - Pilot study - combination product trial

Phase 4

Conditions: N80-N98
Noninflammatory disorders of female genital tract

Registration Number: DRKS00023649

Lead Sponsor: BioRegen Biomedical (Changzhou) Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 60

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
- To determinate the frequency of new peritoneal adhesions in the pelvic or abdominal cavity.<br>- To determinate the frequency of re-formed peritoneal adhesions in the pelvic or abdominal cavity. <br>- To evaluate the manageability of BioRegen crosslinked hyaluronic acid gel during application on peritoneal surfaces. <br>- To determine the type and rate of complications. <br>