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| Name | Class |
|---|---|
| Proxima CRO | INDUSTRY |
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) | Device | Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen's Kappa Coefficient (κ) | Statistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement. | Up to 8 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography. | Up to 8 hours post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Genereux, M.D. | Gagnon Cardiovascular Institute, Morristown Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States | ||
| Morristown Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24282682 | Background | Nguyen CT, Lee E, Luo H, Siegel RJ. Echocardiographic guidance for diagnostic and therapeutic percutaneous procedures. Cardiovasc Diagn Ther. 2011 Dec;1(1):11-36. doi: 10.3978/j.issn.2223-3652.2011.09.02. | |
| 21160056 | Background | Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saranas Early Bird Bleed Monitoring System (EBBMS) | Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2018 |
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| Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography |
Specificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography. |
| Up to 8 hours post procedure |
| Morristown |
| New Jersey |
| 07960 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| 13057644 | Background | SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available. |
| 2788227 | Background | Babu SC, Piccorelli GO, Shah PM, Stein JH, Clauss RH. Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization. J Vasc Surg. 1989 Aug;10(2):113-6. doi: 10.1067/mva.1989.0100113. |
| 11246238 | Background | Chandrasekar B, Doucet S, Bilodeau L, Crepeau J, deGuise P, Gregoire J, Gallo R, Cote G, Bonan R, Joyal M, Gosselin G, Tanguay JF, Dyrda I, Bois M, Pasternac A. Complications of cardiac catheterization in the current era: a single-center experience. Catheter Cardiovasc Interv. 2001 Mar;52(3):289-95. doi: 10.1002/ccd.1067. |
| 14556868 | Background | Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian N, Pinnow EE, Kent KM, Pichard AD, Satler LF, Weissman NJ, Lindsay J, Fuchs S. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions. Am J Cardiol. 2003 Oct 15;92(8):930-5. doi: 10.1016/s0002-9149(03)00972-x. |
| 17421023 | Background | Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, Slater J. Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):961-6. doi: 10.1002/ccd.21087. |
| 14563340 | Background | Moscucci M, Fox KA, Cannon CP, Klein W, Lopez-Sendon J, Montalescot G, White K, Goldberg RJ. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003 Oct;24(20):1815-23. doi: 10.1016/s0195-668x(03)00485-8. |
| 20824761 | Background | Crudu V, Blankenship J, Berger P, Scott T, Skelding K. Complications related to access site after percutaneous coronary interventions: are the adverse events underreported? Catheter Cardiovasc Interv. 2011 Apr 1;77(5):643-7. doi: 10.1002/ccd.22759. Epub 2011 Mar 8. |
| 15895402 | Background | Sherev DA, Shaw RE, Brent BN. Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention. Catheter Cardiovasc Interv. 2005 Jun;65(2):196-202. doi: 10.1002/ccd.20354. |
| 7990185 | Background | Kent KC, Moscucci M, Mansour KA, DiMattia S, Gallagher S, Kuntz R, Skillman JJ. Retroperitoneal hematoma after cardiac catheterization: prevalence, risk factors, and optimal management. J Vasc Surg. 1994 Dec;20(6):905-10; discussion 910-3. doi: 10.1016/0741-5214(94)90227-5. |
| 8677663 | Background | Fruhwirth J, Pascher O, Hauser H, Amann W. [Local vascular complications after iatrogenic femoral artery puncture]. Wien Klin Wochenschr. 1996;108(7):196-200. German. |
| 15276106 | Background | Berry C, Kelly J, Cobbe SM, Eteiba H. Comparison of femoral bleeding complications after coronary angiography versus percutaneous coronary intervention. Am J Cardiol. 2004 Aug 1;94(3):361-3. doi: 10.1016/j.amjcard.2004.04.036. |
| 1415915 | Background | Khoury M, Batra S, Berg R, Rama K, Kozul V. Influence of arterial access sites and interventional procedures on vascular complications after cardiac catheterizations. Am J Surg. 1992 Sep;164(3):205-9. doi: 10.1016/s0002-9610(05)81071-2. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saranas Early Bird Bleed Monitoring System (EBBMS) | Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||||
| Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||||
| Renal Insufficiency | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohen's Kappa Coefficient (κ) | Statistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement. | Posted | Number | proportion of agreement | Up to 8 hours post procedure |
|
|
| |||||||||||||||||||||||||||
| Secondary | Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography. | Posted | Count of Participants | Participants | Up to 8 hours post procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | Specificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography. | Posted | Number | Percentage | Up to 8 hours post procedure |
|
|
5 months
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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 | Saranas Early Bird Bleed Monitoring System (EBBMS) | Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. | 2 | 60 | 9 | 60 | 28 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clot on right atrium of tricuspid valve | Cardiac disorders | Non-systematic Assessment |
| ||
| CAD with acute ischemia | Cardiac disorders | Non-systematic Assessment |
| ||
| Symptomatic anemia | General disorders | Non-systematic Assessment |
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| Hypertension/SOB/Fluid overload | General disorders | Non-systematic Assessment |
| ||
| Coronary or RV perforation w cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
| ||
| Prolonged bleeding from left groin | Vascular disorders | Non-systematic Assessment |
| ||
| Pseudoaneurysm | Vascular disorders | Non-systematic Assessment |
| ||
| 2:1 High Grade AV Block | Cardiac disorders | Non-systematic Assessment |
| ||
| CVA / Bleed | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 2:1 High Grade AV Block | Cardiac disorders | Non-systematic Assessment |
| ||
| A-V Fistula | Vascular disorders | Non-systematic Assessment |
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| Blood Loss Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Atrial Fib & RVR | Cardiac disorders | Non-systematic Assessment |
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| Back Pain | General disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| CVA | General disorders | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| EKG Changes | Cardiac disorders | Non-systematic Assessment |
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| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment |
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| Fever 100.8 Unknown Source | General disorders | Systematic Assessment |
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| Generalized Pain | General disorders | Non-systematic Assessment |
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| Gron Pain | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Hyperkalemia | Renal and urinary disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Hypotension | General disorders | Systematic Assessment |
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| New LBBB | Cardiac disorders | Systematic Assessment |
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| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Leukocystosis | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| New Prolonged P-R Interval | Cardiac disorders | Non-systematic Assessment |
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| Polyarthralgias | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pseudoaneurysm | Vascular disorders | Non-systematic Assessment |
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| R Temporal Artery Bleed | Vascular disorders | Non-systematic Assessment |
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| Right Arm Pain - Generalized | General disorders | Non-systematic Assessment |
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| Right Upper Extremity Swelling | General disorders | Non-systematic Assessment |
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| SOB & Fluid Retention | General disorders | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Worsening Heart Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Worsening Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zaffer Syed | Saranas, Inc. | 833-375-9273 | zaffer@saranas.com |
| Aug 18, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2018 | Sep 4, 2020 | ICF_002.pdf |
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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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