Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352177
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-08
Brief Title:
Digital Therapeutic Lifestyle Intervention Program for Patients with MASLD
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients with MASLD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENLIGHTEN
Brief Summary:
The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH People who have MASH the progressive subtype of MASLD have the highest risk for liver disease progression and poor outcomes including cirrhosis and hepatocellular carcinoma and greater overall mortality Thus these participants are expected to experience the greatest benefit from treatment
This is a randomized controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care The study includes a screening period up to 2 wks followed by randomization 52-wk treatment period and 12-wk follow-up period total duration up to 64 wks
This is a randomized controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care The study includes a screening period up to 2 wks followed by randomization 52-wk treatment period and 12-wk follow-up period total duration up to 64 wks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None