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

Last updated: May 28, 2025
Sponsor: HAN Biomedical Inc
Overall Status: Completed

Phase

N/A

Condition

Blood Clots

Treatment

"HANBIO" Gauze (Sterilized, 1% Collagen)

Clinical Study ID

NCT06715696
HAN2018001-CT01
  • Ages 20-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent form.

Exclusion

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 asprimary hemostasis.

  • Subject has participated in another clinical trial within the past 30 days.

  • Subjects with any pre-operative or intra-operative findings that may precludeconduct of the study procedure or unable to evaluate the outcomes.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: "HANBIO" Gauze (Sterilized, 1% Collagen)
Phase:
Study Start date:
December 15, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

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