CompletedNot Applicable

The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.

Taiwan40 participantsStarted 2024-12-15

Plain-language summary

The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.

Who can participate

Age range

20 Years – 70 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 between 20 and 70 years of age. * Subject scheduled for a non-emergent, gynecological surgery. * Subject has an identified bleeding site/area intraoperatively. * Subject is willing to comply with all aspects of the study and have signed informed consent form. Exclusion Criteria: * Pregnant or lactating female. * The wound is chronic wound that not healed within 8 weeks, e.g. ulcers. * The wound is caused by radiation or burns. * Subject is sensitive or allergic to collagen. * Subject is sensitive or allergic to polyester (PET). * Subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia). * Subject receives anticoagulants or antiplatelets. * Subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis. * Subject has participated in another clinical trial within the past 30 days. * Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.

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

Average Time(sec) to achieve hemostasis

Timeframe: 3 min

Trial details

NCT IDNCT06715696

SponsorHAN Biomedical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Wounds and Injuries trials