The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study) (NCT04638855) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)
South Korea223 participantsStarted 2010-09-08
Plain-language summary
This study was designed to assess the safety and efficacy of MEDICURTAIN, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.
Who can participate
Age range
20 Years – 60 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
. Woman who is between 20\~80 years of age.
. Woman who is reserved elective hysteroscopy for
. Woman who signed an informed consent form prior to the investigation.
Exclusion criteria
. Presence of tumor or inflammatory disease in other organs.
. Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator.
. Subject who is not eligible for re-operation or hysteroscopy
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
Outcome Measure: comparison between treated group and untreated control group for the adhesion rate