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Procedure

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GATT-PatchExperimental Treatment1 Intervention

Hemostatic Patch

Group II: SURGICEL® OriginalActive Control1 Intervention

Hemostatic Patch

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GATT-Patch

2021

N/A

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GATT Technologies BVLead Sponsor

2 Previous Clinical Trials

177 Total Patients Enrolled

Stuart Head, MD PhDStudy DirectorGATT Technologies BV

1 Previous Clinical Trials

47 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what quantity of healthcare facilities is the trial currently underway?

"Five medical centres are actively involved in this trial, with Washington University in Saint Louis, Weill-Cornell of New york City and Atrium Health of Charlotte being the prime ones. Moreover, two more research institutes have joined the initiative."

Answered by AI

What is the total aggregate of participants involved in this experiment?

"In order to conduct the trial, GATT Technologies BV must enroll 50 patients that meet eligibility criteria. Locations such as Washington University in St Louis and Weill-Cornell College of Medicine are participating sites for this investigation."

Answered by AI

Are new participants being enrolled in this clinical research currently?

"Affirmative. Clinicaltrials.gov records indicate that this study, which was first published on October 6th 2023 is still recruiting patients. The research team needs to find 50 volunteers from 5 different medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery

2023. "GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900037.

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