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Enrollment too low, not meeting objectives
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The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.
This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrophilic BioMaterial | Active Comparator | Hydrophilic BioMaterial- HydroPICC |
|
| Thermoplastic Polyurethane | Active Comparator | TPU- 4 French Single Lumen PowerPICC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrophilic Biomaterial | Device | PICC made out of a Hydrophilic Biomaterial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic Thrombosis Rate | Rate of asymptomatic thrombosis measured using ultrasound technology for each group | 7 days post insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology | 14 days post insertion |
| Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Bahl, MD | Beaumont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrophilic BioMaterial | Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial |
| FG001 | Thermoplastic Polyurethane | TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated due to enrollment difficulties and no analysis was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrophilic BioMaterial | Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial |
| BG001 | Thermoplastic Polyurethane | TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Asymptomatic Thrombosis Rate | Rate of asymptomatic thrombosis measured using ultrasound technology for each group | number of subjects with asymptomatic thrombosis measured at Day 7 post insertion using ultrasound technology | Posted | Count of Participants | Participants | 7 days post insertion |
|
Approximately 3 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 | Hydrophilic BioMaterial | Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| superficial venous thrombosis of arm | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Hanley | Access Vascular Inc. | 1-781-538-6594 | 101 | bhanley@accessvascularinc.com |
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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 | Apr 28, 2021 | Oct 7, 2022 | Prot_SAP_000.pdf |
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Randomized control
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| Thermoplastic Polyurethane | Device | PICC made out of a thermoplastic polyurethane material |
|
|
| 7 days post insertion |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology | number of subjects with symptomatic thrombosis measured using ultrasound technology at day 14 | Posted | Count of Participants | Participants | 14 days post insertion |
|
|
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| Secondary | Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology | number of subjects with symptomatic thrombosis measured with ultrasound technology at day 7 | Posted | Count of Participants | Participants | 7 days post insertion |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Thermoplastic Polyurethane | TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material | 0 | 4 | 0 | 4 | 1 | 4 |
| left lower quadrant pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| lung Nodule | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| deep venous thrombosis arm | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
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