NCT07830797

Brief Summary

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/semi-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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P50-P75 for phase_3

Timeline
11mo left

Started Sep 2026

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Sep 2026Aug 2027

First Submitted

Initial submission to the registry

September 7, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 8, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Expected
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 7, 2026

Last Update Submit

September 15, 2026

Conditions

Surgical Bleeding

Keywords

HemostasisAbsorbable GelatinFluid GelatinSurgical Hemostasis

Outcome Measures

Primary Outcomes (1)

  • 5-Minute Hemostasis Success Rate

    Intraoperative (Day of surgery)

Secondary Outcomes (4)

  • 3-Minute Hemostasis Success Rate

    Intraoperative (Day of surgery)

  • Wound Hemostasis Time (T)

    Intraoperative (Day of surgery)

  • Total Postoperative Drainage Volume

    Perioperative period (time from end of surgery to patient's removal of drainage tube)

  • Device Usability Evaluation

    Intraoperative (Day of surgery)

Study Arms (2)

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.

Device: Absorbable Hemostatic Fluid Gelatin

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

Device: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix

Interventions

Absorbable Hemostatic Fluid GelatinDEVICE

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.

Absorbable Hemostatic Fluid Gelatin
Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic MatrixDEVICE

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

SURGIFLO™ Hemostatic Matrix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥18 years;
  • \. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology;
  • \. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS).

You may not qualify if:

  • \. Allergy to porcine gelatin or refusal of porcine-derived products;
  • \. INR\>1.5 or PLT\<100×10⁹/L;
  • \. Severe hepatic/renal dysfunction;
  • \. Pregnancy/lactation;
  • \. Participation in another trial within 30 days;
  • \. Unsuitable per investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yuchuan Zhang

CONTACT

+86 18666661546zhangyuchuan@medprin.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 21, 2026

Study Start

September 8, 2026

Primary Completion

September 8, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share