GATT-Patch for Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intermountain Healthcare, Murray, UT
Hemorrhage+4 More
GATT-Patch - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.

Eligible Conditions

  • Hemorrhage
  • Intraoperative Blood Loss
  • Liver Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 5 years

5 years
Cancer-free survival
Local recurrence of liver cancer at the resection
Overall survival
Week 6
Rate of subjects with liver resection surface complications on ultrasound
Day 0
GATT-Patch device-specific user satisfaction questionnaire
System Usability Score (SUS) user satisfaction questionnaire
Day 30
Aspect of postoperative drainage
Mean total hospitalization time
Number and type of blood transfusions
During postoperative 3-months follow-up
Rate of subjects requiring reoperation
During surgical procedure
Amount of hemostatic material needed versus bleeding surface
Estimated blood loss
Kaplan-Meier estimated distribution of time to hemostasis
Mean time to hemostasis (seconds)
Procedure duration
Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point
Rate of subjects with hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 seconds
Rate of subjects with rebleeding after 10 minutes but before subject closure
Rate of subjects with treatment failure
Day 30
Mean duration of ICU stay

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

TachoSil
1 of 2
GATT-Patch
1 of 2
Active Control
Experimental Treatment

130 Total Participants · 2 Treatment Groups

Primary Treatment: GATT-Patch · No Placebo Group · N/A

GATT-Patch
Device
Experimental Group · 1 Intervention: GATT-Patch · Intervention Types: Device
TachoSil
Drug
ActiveComparator Group · 1 Intervention: TachoSil · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GATT-Patch
2021
N/A
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Closest Location: Intermountain Healthcare · Murray, UT
Photo of utah 1Photo of utah 2Photo of utah 3
2008First Recorded Clinical Trial
1 TrialsResearching Hemorrhage
21 CompletedClinical Trials

Who is running the clinical trial?

GATT Technologies BVLead Sponsor
1 Previous Clinical Trials
47 Total Patients Enrolled
1 Trials studying Hemorrhage
47 Patients Enrolled for Hemorrhage
Hans de WiltPrincipal InvestigatorRadboud UMC Nijmegen, The Netherlands
James GuarreraPrincipal InvestigatorRutgers New Jersey Medical School, Newark, NJ, USA

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are scheduled to undergo elective open surgery on the liver.
You are 22 years of age or older at the time of enrollment.
You are willing and able to give written informed consent for the clinical investigation participation.
The Investigator must be able to identify a target bleeding site at the liver resection plane for which any applicable conventional means for hemostasis (e.g.
You have a target bleeding site with a SBSS of 1, 2, or 3 (e.g.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.