Hemostasis
Conditions
Brief summary
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
Detailed description
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. This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites. The subjects will be followed at hospital charge and 6 weeks postoperatively. The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. Secondary endpoints of this clinical investigation consist of: * Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and * Incidence of adverse events through final follow-up.
Interventions
DEVICEHEMOBLAST 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.
Sponsors
Biom'Up France SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery; * Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; * Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and * Subject is 21 years of age or older. * Subject does not have an active or suspected infection at the surgical site; * Subject in whom the Investigator is able to identify a target bleeding site (TBS) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and * Subject has a TBS with an SBSS score of 1, 2, or 3.
Exclusion criteria
* • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure; * Subject is undergoing a spinal surgical procedure; * Subject is undergoing a neurologic surgical procedure; * Subject is undergoing an emergency surgical procedure; * Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; * Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter and/or International Normalized Ratio \> 1.5 within 4 weeks of surgery; * Subject had chronic corticosteroid use within 2 weeks prior to surgery; * Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery; * Subject has an active or suspected infection at the surgical site; * Subject has had or has planned any organ transplantation; * Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent; * Subject has ASA classification of \> 4; * Subject has a life expectancy of less than 3 months; * Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study; * Subject has a documented severe congenital or acquired immunodeficiency; * Subject has religious or other objections to porcine or bovine components; * Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant; * Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and * Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators | Intraoperative | The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic Within 6 Minutes | Intraoperative | Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application |
| Hemostasis Within 10 Minutes | Intraoperative | Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application |
| Hemostasis Within 3 Minutes | Intraoperative | Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application |
| Adverse Events | 6 +/- 2 weeks after implant | Incidence of adverse events through final follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEMOBLAST 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. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | HEMOBLAST |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 62.8 Years STANDARD_DEVIATION 8.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 15 / 27 |
| serious Total, serious adverse events | 4 / 27 |
Outcome results
Primary
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Time frame: Intraoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEMOBLAST | Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators | 0.7754 Kappa statistic |
Secondary
Adverse Events
Incidence of adverse events through final follow-up
Time frame: 6 +/- 2 weeks after implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST | Adverse Events | 15 Participants |
Secondary
Hemostasis Within 10 Minutes
Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST | Hemostasis Within 10 Minutes | 22 Participants |
Secondary
Hemostasis Within 3 Minutes
Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST | Hemostasis Within 3 Minutes | 12 Participants |
Secondary
Hemostatic Within 6 Minutes
Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST | Hemostatic Within 6 Minutes | 19 Participants |