GATT-Patch vs SURGICEL® for Surgical Bleeding

Not currently recruiting at 7 trial locations

Overseen By Katheryn Peterson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GATT Technologies BV

Must not be taking: Antithrombotics

Disqualifiers: Pregnancy, Infection, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different patches to control bleeding during minimally invasive liver and gallbladder surgeries. It compares the new GATT-Patch with the commonly used SURGICEL® Original to determine which is more effective for minimal, mild, or moderate bleeding. Suitable participants include those scheduled for robotic or laparoscopic liver surgery, such as gallbladder removal, where traditional methods to stop bleeding are insufficient.

As an unphased trial, this study allows participants to contribute to advancements in surgical bleeding control.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude people taking multiple antithrombotic therapies (blood thinners) in therapeutic doses, except for acetylsalicylic acid (aspirin). It's best to discuss your specific medications with the trial team.

What prior data suggests that these hemostatic patches are safe for surgical bleeding management?

Research has shown that the GATT-Patch has been tested on patients to help manage bleeding during surgery. In one study, the patch was applied to 63 bleeding areas in 47 patients and successfully stopped the bleeding without major safety concerns. Another study examined its use in liver surgeries and found that patients tolerated it well, experiencing no severe side effects.

In contrast, SURGICEL® Original is a well-known product already used in surgeries to control bleeding. It is generally considered safe and effective, with a long history of use in clinical settings.

These findings suggest that both the GATT-Patch and SURGICEL® Original are safe for controlling surgical bleeding, with minimal risk of serious side effects. This makes both options promising for those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GATT-Patch because it offers a novel approach to managing surgical bleeding. Unlike traditional hemostatic agents that often rely on older methods, the GATT-Patch is designed as an advanced hemostatic patch. Its unique features may include enhanced adhesion properties and faster activation, potentially leading to quicker and more effective bleeding control during surgeries. This innovation could provide surgeons with a more efficient tool to manage bleeding, improving patient outcomes in the operating room.

What evidence suggests that this trial's treatments could be effective for managing surgical bleeding?

Research has shown that the GATT-Patch, which participants in this trial may receive, effectively controls bleeding during surgery. One study found it stopped bleeding in 97.4% of patients, outperforming products like Veriset™ and TachoSil in similar situations. The GATT-Patch is designed to act quickly, often stopping bleeding within 10 seconds during surgery. These findings suggest that the GATT-Patch is a promising option for managing mild to moderate bleeding during liver and gallbladder surgeries. Meanwhile, SURGICEL® Original, the comparator in this trial, is also being evaluated for its effectiveness in controlling surgical bleeding. ^{1 2 3 6 7}

Who Is on the Research Team?

Stuart Head, MD PhD

Principal Investigator

GATT Technologies BV

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older needing elective minimally invasive liver or gallbladder surgery. Participants must be able to consent and follow the study's procedures, with a specific type of bleeding during surgery that can't be stopped by usual methods like stitches. Excluded are those with certain blood conditions, severe allergies to product ingredients, pregnant or breastfeeding women, and those on multiple blood-thinning drugs.

Inclusion Criteria

Subject is willing and able to give written informed consent for the clinical investigation participation

I am 22 years old or older.

My surgery will be minimally invasive without using a hand port.

Exclusion Criteria

Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1), porcine gelatin

I am scheduled for a specific liver surgery to remove a part of my liver.

I have had or am planning to have an organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo minimally invasive liver and gallbladder surgery with either GATT-Patch or SURGICEL® Original for hemostasis

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative drainage volume and complications during hospitalization

Up to 30 days

Follow-up

Participants are monitored for liver resection surface complications and user satisfaction at follow-up visits

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for any reoperation requirements during a 3-month follow-up period

3 months

What Are the Treatments Tested in This Trial?

Interventions

• GATT-Patch
• SURGICEL® Original

Trial Overview The trial compares GATT-Patch versus SURGICEL® Original in controlling minimal to moderate bleeding during keyhole surgeries on the liver or gallbladder. Patients will randomly receive one of these treatments during their operation to see which one manages bleeding better.

How Is the Trial Designed?

Group I: GATT-Patch Experimental Treatment 1 Intervention

Hemostatic Patch

Group II: SURGICEL® Original Active Control 1 Intervention

Hemostatic Patch

Who Is Running the Clinical Trial?

GATT Technologies BV

Lead Sponsor

Trials

3

Recruited

240+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424001446

Clinical Safety and Performance of GATT-Patch for ... The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, ...

2. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(24)00144-6/fulltext

Clinical Safety and Performance of GATT-Patch for ... GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36918896/

Efficacy of a novel polyoxazoline-based hemostatic patch ... In experiment 3, GATT-Patch, Veriset™, TachoSil and GFC Blank reached hemostasis after 10s in 100%, 42.8%, 7.1% and 14.3%, respectively, and at ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05385952

GATT-Patch Versus TachoSil in Liver Surgery GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38640617/

Clinical Safety and Performance of GATT-Patch for ... GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04819945

Clinical Safety and Performance of GATT-Patch in Open ... The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.

7. pure.eur.nl pure.eur.nl/files/145875788/Clinical_Safety_and_Performance_of_GATT-Patch_for_Hemostasis_in_Minimal_to_Moderate_Bleeding_During_Open_Liver_Surgery.pdf

Clinical Safety and Performance of GATT-Patch for ... Intraoperatively, patients had to have minimal, mild, or moderate bleeding (Severity Bleeding Surface Scale [SBSS] of 1,. 2, or 3)15 at a target ...