Trial Outcomes & Findings for HEMOBLAST Pilot Clinical Investigation (NCT NCT02502019)

NCT ID: NCT02502019

Last Updated: 2019-02-15

Results Overview

The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	HEMOBLAST Subjects received the investigational device, HEMOBLAST Bellows.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HEMOBLAST Pilot Clinical Investigation

Baseline characteristics by cohort

Measure	HEMOBLAST n=27 Participants All subjects will have the investigational device implanted HEMOBLAST Bellows: HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	62.8 Years STANDARD_DEVIATION 8.64 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	6 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.

Outcome measures

Measure	HEMOBLAST n=27 Participants Subjects received the investigational device, HEMOBLAST Bellows.
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators	0.7754 Kappa statistic

SECONDARY outcome

Timeframe: Intraoperative

Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application

Outcome measures

Measure	HEMOBLAST n=24 Participants Subjects received the investigational device, HEMOBLAST Bellows.
Hemostatic Within 6 Minutes	19 Participants

SECONDARY outcome

Timeframe: Intraoperative

Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application

Outcome measures

Measure	HEMOBLAST n=24 Participants Subjects received the investigational device, HEMOBLAST Bellows.
Hemostasis Within 10 Minutes	22 Participants

SECONDARY outcome

Timeframe: Intraoperative

Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application

Outcome measures

Measure	HEMOBLAST n=24 Participants Subjects received the investigational device, HEMOBLAST Bellows.
Hemostasis Within 3 Minutes	12 Participants

SECONDARY outcome

Timeframe: 6 +/- 2 weeks after implant

Incidence of adverse events through final follow-up

Outcome measures

Measure	HEMOBLAST n=27 Participants Subjects received the investigational device, HEMOBLAST Bellows.
Adverse Events	15 Participants

Adverse Events

HEMOBLAST

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	HEMOBLAST n=27 participants at risk Subjects received the investigational device, HEMOBLAST Bellows.
General disorders Metabolic encephalopathy	3.7% 1/27 • Number of events 1
General disorders Non-occlusive thrombus and nonresponsiveness	3.7% 1/27 • Number of events 1
Hepatobiliary disorders Pancreatic leak	3.7% 1/27 • Number of events 1
General disorders Syncopy	3.7% 1/27 • Number of events 1

Other adverse events

Measure	HEMOBLAST n=27 participants at risk Subjects received the investigational device, HEMOBLAST Bellows.
General disorders Non-serious AE	55.6% 15/27 • Number of events 15

Additional Information

Dr. William Spotnitz, Chief Medical Officer

Biom'Up

Phone: 352-514-5009

Email: wspotnitz@gmail.com

Results disclosure agreements

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