GATT-Patch vs SURGICEL® for Surgical Bleeding

N/A

Recruiting

Research Sponsored by GATT Technologies BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during postoperative 3-months follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a new patch to a standard patch to see which is better for stopping bleeding during liver and gallbladder surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions if sensitive to any components (like porcine gelatin), infection at the site of application, and possibly inadequate control of bleeding requiring additional interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during postoperative 3-months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during postoperative 3-months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and during postoperative 3-months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of hemostasis within 7 minutes from introduction of the first (piece of) patch through the trocar without rebleeding at the 10-minute time point from initiating pressure on the entire surface of the hemostatic agent

Secondary study objectives

Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent

Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis

Median time in seconds from introducing the hemostatic agent through the trocar to initiating pressure on the entire surface of the agent

+5 more

Other study objectives

Amount of hemostatic material needed versus bleeding surface

Conversion from minimally invasive to open surgery, and reasons for conversion

Duration of Intensive Care Unit (ICU) stay

+9 more