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| Name | Class |
|---|---|
| Arizona Liver Health | UNKNOWN |
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This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.
The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. The study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this feasibility study will have access to the treatment for 3- months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- BT-NCBT-00x | Experimental | The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. BT-NCBT-00x is accessed via the participants' smartphone after downloading from the phone's corresponding app store. Participants will receive behavioral support by the Better Therapeutics patient services team in the form of phone calls as necessary or requested by the patient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-NCBT-00X | Device | the intervention group will consist of 20 patients to receive the BT-NCBT-00X treatment for 90 days. They will receive a baseline MRI-PDFF, Fibroscan and have the tests repeated at 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| change in percent liver fat | Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF ≥ 10%, as measured by MRI-PDFF. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat- all participants | Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF | 90 days |
| Reduction in Percent Liver fat | Percent of participants who achieve ≥ 30% change in PDFF from baseline to end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | 85224 | United States | ||
| Arizona Liver Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39132187 | Derived | Alkhouri N, Edwards K, Berman M, Finn H, Escandon R, Lupinacci P, Guthrie N, Coste A, Topete J, Noureddin M. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Adv. 2023 Oct 1;3(1):9-16. doi: 10.1016/j.gastha.2023.08.019. eCollection 2024. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
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open label
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| 90 days |
| Peoria |
| Arizona |
| 85381 |
| United States |