Trial Outcomes & Findings for EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging (NCT NCT05307783)
NCT ID: NCT05307783
Last Updated: 2025-01-22
Results Overview
The primary performance endpoint will be clinical success defined as cessation of bleeding post-embolization and absence of rebleeding at the treated site requiring reintervention (repeat embolization or additional surgery), within 24 hours.
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
24 hours
Results posted on
2025-01-22
Participant Flow
Participant milestones
| Measure |
Device
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Device
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
Baseline characteristics by cohort
| Measure |
Device
n=101 Participants
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 20.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American / Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/ White
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Pacific Islander
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported / Refuse to disclose
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary performance endpoint will be clinical success defined as cessation of bleeding post-embolization and absence of rebleeding at the treated site requiring reintervention (repeat embolization or additional surgery), within 24 hours.
Outcome measures
| Measure |
Device
n=101 Participants
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours
|
100 Participants
|
PRIMARY outcome
Timeframe: 24 hoursAbsence of unanticipated serious adverse device effects within 24 hours.
Outcome measures
| Measure |
Device
n=101 Participants
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)
|
101 Participants
|
Adverse Events
Device
Serious events: 12 serious events
Other events: 3 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Device
n=101 participants at risk
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Vascular disorders
Bleeding complication
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Surgical and medical procedures
Hematoma
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Vascular disorders
Hemorrhage
|
2.0%
2/101 • Number of events 2 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.0%
2/101 • Number of events 2 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Infections and infestations
Peritonitis
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Vascular disorders
Hematoma of the left kidney
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Hepatobiliary disorders
Progressive deterioration of liver function
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
General disorders
Multi-organ failure
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Hepatobiliary disorders
Cirrhosis
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Gastrointestinal disorders
Ischemic colitis
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
Other adverse events
| Measure |
Device
n=101 participants at risk
Treated with EmboCube Embolization Gelatin
|
|---|---|
|
Vascular disorders
Aneurysm
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Renal and urinary disorders
Renal failure/renal insufficiency
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
1/101 • Number of events 1 • Data collection included endpoints relating to safety and effectiveness during the period from index procedure through 28 days post-procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place