Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381349
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-15
Brief Title:
Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
Sponsor:
Chris Varghese
Organization:
University of Auckland New Zealand
Study Overview
Official Title:
Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System GPOEM-GEMS
Status:
RECRUITING
Status Verified Date:
2024-05
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:
GPOEM-GEMS
Brief Summary:
Gastric peroral endoscopic myotomy GPOEM is a minimally-invasive procedure that involves dividing the pylorus to enhance gastric emptying in gastroparesis patients This is a single-arm multi-centre prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes The investigators further aim to develop a clinical decision rule to inform patient selection Gastric Alimetry will be conducted 1 month prior to GPOEM All subjects will then be followed up for 12 months
Detailed Description:
This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients primary clinical team
Patients as part of this study will undergo a baseline assessment via Gastric Alimetry and concurrent symptom quality of life and health psychology questions
GPOEM will be performed as per standard site protocol with data captured in RDCap
Patients will be followed up at 1-month 3-month 6-months and 12-months using the myCap REDCap app
Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure
Patients as part of this study will undergo a baseline assessment via Gastric Alimetry and concurrent symptom quality of life and health psychology questions
GPOEM will be performed as per standard site protocol with data captured in RDCap
Patients will be followed up at 1-month 3-month 6-months and 12-months using the myCap REDCap app
Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None