Functionality and Accuracy of the smART System in Real-Life ICU Settings
Functionality and Accuracy of the smART System in Real-Life ICU Settings
| Sponsors |
Lead Sponsor: ART Medical Ltd. |
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| Source | ART Medical Ltd. |
| Brief Summary | Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Sheba study site there were 2 participants and in the Jefferson study site (identifier NCT03198988) there were 8 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV). |
| Overall Status | Terminated | ||||||||||||||||
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| Start Date | 2018-11-07 | ||||||||||||||||
| Completion Date | 2020-07-17 | ||||||||||||||||
| Primary Completion Date | 2020-07-17 | ||||||||||||||||
| Phase | N/A | ||||||||||||||||
| Study Type | Interventional | ||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 2 |
| Condition | |
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| Intervention |
Intervention Type: Device Intervention Name: smART Feeding Tube System Description: Replacing generic feeding tube with smART Feeding Tube System. Arm Group Label: General |
| Eligibility |
Criteria:
Inclusion Criteria: - Males and females 18 years or older - Patient has already been admitted to ICU - Patient requires enteral feeding - Patients receiving Proton Pump Inhibitors (PPI) therapy - Informed consent by independent physician and next of kin - ICU ventilated patients Exclusion Criteria: - Patients with anomalies or diseases of the esophagus and or stomach. - Patients with known sensitivities or allergies to any of the feeding tube materials - Inability to place patient in semi-Fowler's position. - Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder) - Pregnancy - Recent abdominal surgery (less than 30 days) Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
| Overall Official |
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| Overall Contact | Contact information is only displayed when the study is recruiting subjects. | |||
| Location |
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| Location Countries |
Israel |
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| Verification Date |
2020-09-01 |
| Responsible Party |
Type: Sponsor |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 1 |
| Arm Group |
Label: General Type: Experimental Description: One arm study: smART Feeding Tube System. |
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Prevention Masking: None (Open Label) |
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