Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560307
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Study of Enhanced Programming Stimulation With the Enterra Therapy System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examination of Programming With the Enterra Therapy System in a Double-Blinded Randomized Prospective Study In the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPEDITE
Brief Summary:
The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis improve symptoms in a faster amount of time and improve quality of life measures
Participants in this study will be evaluated for study entry criteria have an Enterra Therapy System implanted and be randomly assigned to one of two programming strategies Participants will answer daily questions about their gastroparesis symptoms on an application with their phonetablet Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits
Participants will be involved in the study for up to six months after treatment assignment
Programming parameters in the study are within currently approved labeling
Participants in this study will be evaluated for study entry criteria have an Enterra Therapy System implanted and be randomly assigned to one of two programming strategies Participants will answer daily questions about their gastroparesis symptoms on an application with their phonetablet Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits
Participants will be involved in the study for up to six months after treatment assignment
Programming parameters in the study are within currently approved labeling
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None