A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis) (NCT07764055) | Clinical Trial Compass
CompletedPhase 3
A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)
China288 participantsStarted 2022-11-09
Plain-language summary
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial. The purpose is to evaluate the safety and effectiveness of the absorbable multilayer fibrillar regenerated oxidized cellulose in controlling capillary, venous, and small arteriole bleeding during surgical procedures when ligation or other conventional methods are ineffective or impractical. A total of 288 subjects (144 in the test group, 144 in the control group) will be enrolled across 6 centers (General Surgery, Cardiothoracic Surgery, Gynecology, and Urology). Subjects will be followed up at 30±15 days and 180±30 days post-surgery. The primary efficacy endpoint is the hemostasis success rate within 5 minutes.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Age ≥ 18 years, any gender.
* Patients scheduled for surgical procedures where adjunctive hemostasis is anticipated.
* Patient and/or legal guardian has provided written informed consent.
Exclusion Criteria:
* Participated in another clinical trial within 1 month prior to surgery.
* Presence of acute infection.
* Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery.
* Known allergy to regenerated oxidized cellulose.
* History of severe allergies or severe immunodeficiency.
* Severe coagulation dysfunction (e.g., platelet count \< 50×10\^9/L, INR \> 2).
* Life expectancy \< 6 months.
* Pregnant or breastfeeding women.
* Patients deemed non-compliant or unable to complete the study as judged by the investigator.
* Unable to understand the study description provided by the investigator.
* Any other condition deemed unsuitable for participation by the investigator (e.g., extensive trauma, extremely unstable vital signs, life-threatening massive bleeding).
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
Hemostasis Success Rate within 5 Minutes
Timeframe: Intraoperative (Day of surgery)
Trial details
NCT IDNCT07764055
SponsorMedprin Regenerative Medical Technologies Co., Ltd.