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| Name | Class |
|---|---|
| Centauri Medical, Inc. | INDUSTRY |
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The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DynaSense sensor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynaSense sensor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Primary Endpoint | The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events. | Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE. |
| Turn Protocol Compliance | The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system. | Subjects will be followed for the length of hospital stay which is expected to average 5 days. |
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Inclusion Criteria:
Exclusion Criteria:
Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.
Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.
Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.
Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).
Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.
Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.
Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.
Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Pezzani, MD | El Camino Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Camino Hospital | Mountain View | California | 94040 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DynaSense Sensor | All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required. The rate of compliance with prescribed turning protocols was measured using the DynaSense System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who successfully completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | DynaSense Sensor | All subjects who successfully completed the study. |
| 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 | Safety Primary Endpoint | The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events. | Posted | Number | percentage of subjects with ADEs | Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE. |
|
|
Upon removal of the patient sensor (within 5 minutes of removal), the subject's skin was assessed for any ADEs.
If an ADE was present upon sensor removal, the subject's skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.
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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 | DynaSense Sensor | All subjects enrolled in the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema (Skin Redness) | Skin and subcutaneous tissue disorders | Systematic Assessment | Localized erythema (skin redness) following removal of patient sensor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barrett Larson, MD, Chief Medical Officer | Leaf Healthcare, Inc. | 650-701-3652 | barrett.larson@leafhealthcare.com |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Turn Protocol Compliance | The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system. | Posted | Number | 95% Confidence Interval | percentage turn compliance | Subjects will be followed for the length of hospital stay which is expected to average 5 days. |
|
|
|
| 0 |
| 70 |
| 2 |
| 70 |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | Localized itching in skin region where patient sensor was removed. |
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| Skin Irritation/Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation and discomfort following removal of patient sensor. |
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