[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656758":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":11,"armGroups":33,"interventions":46,"overallOfficials":11,"centralContacts":53,"locations":11,"responsibleParty":59,"collaborators":61,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":11},{"fullName":5,"class":6},"Medprin Regenerative Medical Technologies Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"5-Minute Hemostasis Success Rate",null,"Intraoperative (Day of surgery)",[14,16,18,21],{"measure":15,"description":11,"timeFrame":12},"3-Minute Hemostasis Success Rate",{"measure":17,"description":11,"timeFrame":12},"Wound Hemostasis Time (T)",{"measure":19,"description":11,"timeFrame":20},"Total Postoperative Drainage Volume","Perioperative period (time from end of surgery to patient's removal of drainage tube)",{"measure":22,"description":23,"timeFrame":12},"Device Usability Evaluation","Evaluate device usability on the day of surgery. Evaluation items include: 1. Convenience of device assembly; 2. Convenience of product use; 3. Wound adhesion quality; 4. Wound applicability (evaluating applicability across different wound types, such as diffuse bleeding wounds, irregular wounds, and deep cavity wounds, etc.). A 1-5 scoring scale is used: 5=Excellent, 4=Good, 3=Fair, 2=Poor, 1=Very Poor\u002FUnacceptable. Items scoring \\\u003C3 (Poor, Very Poor, Unacceptable) require special attention, and the reasons must be documented.",{"allocation":25,"interventionModel":26,"interventionModelDescription":11,"primaryPurpose":27,"observationalModel":11,"timePerspective":11,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":11,"whoMasked":30},"SINGLE",[31],"PARTICIPANT","This trial enrolls 324 participants (162 per group) across General Surgery, Orthopedics, and Gynecology, with equal allocation per specialty (108 each). Each subject has one Target Bleeding Site (TBS). After conventional hemostasis fails or is not applicable, subjects are randomized to receive either the test or control device. Time from product application (T0) to hemostasis (TF) is recorded. Postoperative follow-up extends to 4 months, assessing adverse events, drainage volume, and laboratory changes.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Absorbable Hemostatic Fluid Gelatin","EXPERIMENTAL","Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery.",[39],"Device: Absorbable Hemostatic Fluid Gelatin",{"label":41,"type":42,"description":43,"interventionNames":44},"SURGIFLO™ Hemostatic Matrix","ACTIVE_COMPARATOR","This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures",[45],"Device: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix",[47,50],{"type":48,"name":35,"description":37,"armGroupLabels":49,"otherNames":11},"DEVICE",[35],{"type":48,"name":51,"description":43,"armGroupLabels":52,"otherNames":11},"Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix",[41],[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Yuchuan Zhang","CONTACT","+86 18666661546","zhangyuchuan@medprin.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[62,65,67,69,72,74],{"name":63,"class":64},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"name":66,"class":64},"Southern Medical University, China",{"name":68,"class":64},"Xi'an Honghui Hospital",{"name":70,"class":71},"The Third Affiliated Hospital of Southern Medical University","OTHER_GOV",{"name":73,"class":64},"Obstetrics & Gynecology Hospital of Fudan University",{"name":75,"class":64},"Zhejiang Provincial People's Hospital","100656758","phase-3-absorbable-hemostatic-fluid-gelatin-trial-100656758",false,"NCT07830797","Absorbable Hemostatic Fluid Gelatin Trial","A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis","Inclusion Criteria:\n\n* 1\\. Age ≥18 years;\n* 2\\. Scheduled for elective\u002Fsemi-elective surgery in General Surgery, Orthopedics, or Gynecology;\n* 3\\. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS).\n\nExclusion Criteria:\n\n* 1\\. Allergy to porcine gelatin or refusal of porcine-derived products;\n* 2\\. INR\\>1.5 or PLT\\\u003C100×10⁹\u002FL;\n* 3\\. Severe hepatic\u002Frenal dysfunction;\n* 4\\. Pregnancy\u002Flactation;\n* 5\\. Participation in another trial within 30 days;\n* 6\\. Unsuitable per investigator.","ALL","18 Years",{"count":86,"type":87},324,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective\u002Fsemi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).",[93],"Surgical Bleeding",[95,96,97,98],"Hemostasis","Absorbable Gelatin","Fluid Gelatin","Surgical Hemostasis","NOT_YET_RECRUITING","2026-09-15",{"date":102,"type":103},"2026-09-21","ACTUAL",{"date":105,"type":87},"2026-09-08",{"date":107,"type":87},"2027-08-31",{"name":5,"class":6}]