Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464926
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra Therapy System NAVIGATE
Sponsor:
Enterra Medical Inc
Organization:
Enterra Medical Inc
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra Therapy System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
NAVIGATE
Brief Summary:
The purpose of this research study is to determine if the Enterra Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea with or without vomiting that have normal gastric emptying
Detailed Description:
Participants in this study will have an Enterra Therapy System implanted and be assigned to a study group Participants will answer daily questions about their nausea and vomiting symptoms and quality of life impacts with their smart device Participants will answer quality of life questionnaires about their symptoms at study visits Participants will be involved in this study for approximately twelve months after their study group is assigned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None