Trial Outcomes & Findings for Clinical Safety and Performance of GATT-Patch in Open Liver Surgery (NCT NCT04819945)

NCT ID: NCT04819945

Last Updated: 2024-09-19

Results Overview

Performance of GATT-Patch in achieving hemostasis at 3 minutes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: During procedure
• Results posted on: 2024-09-19

Participant Flow

A total of 56 patients provided informed consent. There were 47 patients that received GATT-Patch during surgery.

Participant milestones

Measure	GATT-Patch GATT-Patch will be used during Stage I of the trial, after which a pause of the trial will take place for an independent safety assessment by the Data Monitoring Committee. If approved, GATT-Patch will furthermore be used during Stage II of the trial, which will include 39 patients for the primary endpoint analysis of hemostasis.
Overall Study STARTED	47
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	GATT-Patch GATT-Patch will be used during Stage I of the trial, after which a pause of the trial will take place for an independent safety assessment by the Data Monitoring Committee. If approved, GATT-Patch will furthermore be used during Stage II of the trial, which will include 39 patients for the primary endpoint analysis of hemostasis.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Clinical Safety and Performance of GATT-Patch in Open Liver Surgery

Baseline characteristics by cohort

Measure	GATT-Patch n=47 Participants GATT-Patch will be used to control bleeding during open liver surgery. Each surgery will be performed according to the standard procedures at the hospital, with the exception of the use of GATT-Patch. GATT-Patch: Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery
Age, Continuous	59.7 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Previous abdominal surgery, %	29 Participants n=5 Participants
Hereditary blood disorders, %	1 Participants n=5 Participants
Hemoglobin, g/dL	8.3 g/dL STANDARD_DEVIATION 0.8 • n=5 Participants
Platelet count, 10^9/L	219.4 10^9 platelets/L STANDARD_DEVIATION 79.1 • n=5 Participants
Total bilirubin, umol/L	9.3 umol/L STANDARD_DEVIATION 4.9 • n=5 Participants
Indication for surgery Colorectal carcinoma metastases	31 Participants n=5 Participants
Indication for surgery Hepatocellular carcinoma	5 Participants n=5 Participants
Indication for surgery Cholangiocarcinoma	4 Participants n=5 Participants
Indication for surgery Non-colorectal carcinoma metastases	4 Participants n=5 Participants
Indication for surgery Other	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure

Performance of GATT-Patch in achieving hemostasis at 3 minutes

Outcome measures

Measure	GATT-Patch Stage II Patients n=39 Participants Stage II of the trial was used for the primary endpoint analysis of hemostasis, and included 39 patients.	GATT-Patch All Patients n=47 Participants All 47 patients treated with GATT-Patch during Stage I and Stage II of the trial.
Hemostasis	38 Participants	46 Participants

SECONDARY outcome

Timeframe: During procedure

The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals.

Outcome measures

Measure	GATT-Patch Stage II Patients n=39 Participants Stage II of the trial was used for the primary endpoint analysis of hemostasis, and included 39 patients.	GATT-Patch All Patients All 47 patients treated with GATT-Patch during Stage I and Stage II of the trial.
Mean Time to Hemostasis (Seconds)	54.6 seconds Standard Deviation 107.5	—

SECONDARY outcome

Timeframe: During procedure

The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined.

Outcome measures

Measure	GATT-Patch Stage II Patients n=39 Participants Stage II of the trial was used for the primary endpoint analysis of hemostasis, and included 39 patients.	GATT-Patch All Patients All 47 patients treated with GATT-Patch during Stage I and Stage II of the trial.
Hemostasis at Different Timepoints Hemostasis at 30 seconds	32 participants	—
Hemostasis at Different Timepoints Hemostasis at 1 minute	37 participants	—
Hemostasis at Different Timepoints Hemostasis at 90 seconds	37 participants	—
Hemostasis at Different Timepoints Hemostasis at 120 seconds	37 participants	—
Hemostasis at Different Timepoints Hemostasis at 150 seconds	37 participants	—
Hemostasis at Different Timepoints Hemostasis at 3 minutes	38 participants	—

Adverse Events

GATT-Patch All Patients

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	GATT-Patch All Patients n=47 participants at risk All 47 patients treated with GATT-Patch during Stage I and Stage II of the trial.
Gastrointestinal disorders Gastric perforation	2.1% 1/47 • Number of events 1 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Hepatobiliary disorders Biloma	2.1% 1/47 • Number of events 1 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Hepatobiliary disorders Hepatic failure	2.1% 1/47 • Number of events 1 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Infections and infestations Pneumonia	2.1% 1/47 • Number of events 1 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Hepatobiliary disorders Bile leakage	2.1% 1/47 • Number of events 1 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Infections and infestations Abdominal abscess	4.3% 2/47 • Number of events 2 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.

Other adverse events

Measure	GATT-Patch All Patients n=47 participants at risk All 47 patients treated with GATT-Patch during Stage I and Stage II of the trial.
Hepatobiliary disorders Biloma / bile leakage	21.3% 10/47 • Number of events 10 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.
Injury, poisoning and procedural complications Hepatic hematoma	8.5% 4/47 • Number of events 4 • Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit. All events occurring during hospitalization after surgery, as well as occurring within the follow-up timeframe up to the 6-week follow-up visit were marked as adverse events. During hospitalization, systematic physical exams and laboratory assessments were performed and at 6 weeks an abdominal ultrasound was performed.

Additional Information

Dr Stuart Head, MD, PhD, Chief Medical Officer

GATT Technologies B.V.

Phone: +31645306042

Email: s.head@gatt-tech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place