Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Conditions
Brief summary
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
Interventions
DEVICEVeriset™ Hemostatic Patch
Topical Hemostat
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or authorized representative has provided informed consent. * Subject is ≥ 18 years old. * Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach. * Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. * Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure. * TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).
Exclusion criteria
* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding. * Subject has an estimated life expectancy of less than 6 months. * Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment. * Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death. * Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study. * Subject has an active local infection at the TBS. * The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment | Intra-operative (Day 0) | Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieve Hemostasis Within 1 Minute | Intra-operative (Day 0) | Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. |
| Median Time to Achieve Hemostasis | Intra-operative (Day 0) | Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. |
Countries
Austria, Germany
Participant flow
Recruitment details
Subjects who were scheduled for non-emergent, soft tissue procedures performed via an open approach were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.
Pre-assignment details
Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were enrolled into the study. Subjects who did not meet all criteria were considered screen failures and not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Veriset™ Hemostatic Patch Subjects received the topical hemostat Veriset™ Hemostatic Patch | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Veriset™ Hemostatic Patch |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 174.0 centimeters STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 30 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 75.0 kilograms STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 30 |
| serious Total, serious adverse events | 11 / 30 |
Outcome results
Primary
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Veriset™ Hemostatic Patch | Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment | 29 participants |
Comparison: The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.p-value: <0.0001t-test, 1 sided
Secondary
Median Time to Achieve Hemostasis
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Veriset™ Hemostatic Patch | Median Time to Achieve Hemostasis | 1 Minutes |
Comparison: Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.
Secondary
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Veriset™ Hemostatic Patch | Proportion of Subjects Who Achieve Hemostasis Within 1 Minute | 21 participants |
Comparison: The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.p-value: 0.0214t-test, 1 sided