The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Posts… (NCT02166554) | Clinical Trial Compass
CompletedPhase 1/2
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
China216 participantsStarted 2011-06
Plain-language summary
The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female.
* Aged 18-45 years.
* Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions.
* Been willing to comply with all aspects of the treatment and evaluation schedule.
* Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery.
* Provided voluntary written informed consent.
Exclusion Criteria:
* Acute or severe infection.
* Autoimmune diseases such as diabetes etc.
* Abnormal liver/renal and cardiovascular function
* Abnormal blood coagulation
* Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness.
* Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives.
* Concurrent use of systemic antiinflammatory drugs.
* Clinical evidence of cancer.
* Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure.
* Concurrent peritoneal grafting or tubal implantation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The adhesion incidence under moderate/severe category
Timeframe: 9 weeks following primary laparoscopic gynecological surgery