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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veriset™ Hemostatic Patch | Experimental | Topical hemostat |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veriset™ Hemostatic Patch | Device | Topical Hemostat |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative (Day 0) |
| Median Time to Achieve Hemostasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | Austria | |||||
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Veriset™ Hemostatic Patch | Subjects received the topical hemostat Veriset™ Hemostatic Patch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| Intra-operative (Day 0) |
| Hanover |
| Germany |
| München | Germany |
| COMPLETED |
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| NOT COMPLETED |
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Baseline demographic and clinical characteristics are summarized by descriptive statistics for continuous variables, and frequencies and percentages for categorical variables. These analyses were performed on the Treated Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Veriset™ Hemostatic Patch | Subjects received the topical hemostat Veriset™ Hemostatic Patch |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Number | participants | Intra-operative (Day 0) |
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| 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. | Posted | Number | participants | Intra-operative (Day 0) |
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| 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. | Posted | Median | 95% Confidence Interval | Minutes | Intra-operative (Day 0) |
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Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veriset™ Hemostatic Patch | Subjects received the topical hemostat Veriset™ Hemostatic Patch | 11 | 30 | 17 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Mesenteric haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Impaired healing | General disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Bacterial diarrhoea | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
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| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
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| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
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| Laboratory test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
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| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
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| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Impaired healing | General disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Totten | Covidien | 781-839-1729 | Julie.Totten@Covidien.com |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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