ClinicalTrials.gg
RecruitingNCT06664775Updated Jun 30, 2026

A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

A Phase 3 interventional study of TachoSil and Surgicel Original in Hemorrhage, sponsored by Corza Medical GmbH. Recruiting at 9 sites in United States. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Corza Medical GmbH · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
1 Month and older
Sex
All
01

Study summary

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for > 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.

02

Conditions studied

  • Hemorrhage

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03

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's planned enrollment of 116 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Corza Medical GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
  2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
  3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
  4. The TBS size \< 21 cm2/3.3 in2.
  5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.

Exclusion criteria

Exclusion Criteria:

  1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
  2. Congenital or acquired disorders of coagulation.
  3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
  4. Screening \< 9 mg/dL, \< 75 × 103/µL, and/or (INR) > 1.5.
  5. Acute major bleeding during surgery.
  6. Participant with TBS in an actively infected field.
  7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
  8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
  9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
  10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (estimated)

Study arms

  • Experimental
    TachoSil

    Biological: TachoSil

  • Active comparator
    Surgicel Original

    Biological: Surgicel Original

Interventions

  • BiologicalTachoSil

    Adjunct to hemostasis

  • BiologicalSurgicel Original

    Adjunct to hemostasis

06

What researchers measure

Primary outcomes

  1. Hemostatic success within 3 minutes

    Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention

    Time frame: within 3 minutes of study intervention

Secondary outcomes

  1. Hemostatic success within 6 minutes

    Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention

    Time frame: within 6 minutes of study intervention

  2. Study intervention failures

    Proportion of study intervention failures, defined as failure to achieve hemostatic success within 6 minutes after application of study intervention or bleeding requiring additional intervention during the 6 minutes after application of study intervention

    Time frame: within 6 minutes of study intervention

  3. hemostatic success from moderate bleeding within 3 minutes

    Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention

    Time frame: within 3 minutes of study intervention

07

Study locations

9 of 9 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06664775
Lead sponsor
Corza Medical GmbH
Responsible party
Sponsor
First posted
Oct 30, 2024
Start date
Apr 2, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 30, 2026

Study contacts

Jeff Wilson
Contact
Jeff.wilson@corza.com
1 416-578-9058
Michele Young
Contact
Michele.young@corza.com
1 689-316-8809

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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