Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493032
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-24
Brief Title:
The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis andor G-POEM procedure
Detailed Description:
The aim of this protocol is to build on the investigators currently approved study to evaluate the outcomes and predictors of success of Gastric peroral endoscopic myotomy G-POEM The investigators plan to incorporate BSGM in determining the treatment success after G-POEM in patients with refractory gastroparesis and potentially identify a phenotype of gastroparesis patients who may respond more favorably to G-POEM based on their baseline BSGM profile The currently approved G-POEM study IRB 1708840627 and ClinicalTrialsgov ID NCT04434781 at our center tracks patients symptoms and quality of life at baseline and post G-POEM the investigators plan to supplement the existing study by adding BSGM variables Although the investigators have specific outcomes identified the investigators would like to stress that this is a pilot study that will serve to identify patterns and trends that could be studied further in the future using larger cohorts of patients
The investigators primary objective is to evaluate the safety and feasibility BSGM in refractory gastroparesis patients undergoing G-POEM
the investigators will also investigate whether changes in BSGM measures correlate with changes in symptoms and quality of life
Additionally the investigators aim to compare the diagnostic performance of BSGM and gastric emptying scans as depicted on scintigraphy
The investigators primary aim is to assess the feasibility and safety of in gastroparesis patients undergoing G-POEM Clinical success is defined as improvement in GCSI by 1 point or more compared to baseline
The investigators will report four spectral metrics each profiling distinct features of gastric function
Body Surface Gastric Mapping Rhythm IndexTM GA-RI - a measure of gastric rhythm stability
Principal Gastric Frequency - the frequency associated with stable persistent gastric activity as defined by GA-RI
BMI-adjusted amplitude
Fed Fasted Amplitude Ratio ff-AR
Although not directly related to this outcome the investigators will continue our symptom analysis as has been previously done under the existing G-POEM protocol that includes both the pattern and severity of individual symptoms such as vomiting reflux and belching The investigators will continue to assess patient quality of life using standardized questionnaires SF-36 at baseline and 3 months post-G-POEM as is currently done with the existing protocol
This is an addition to an existing study protocol The study will involve patients with refractory gastroparesis proven on a 4-hour solid-phase gastric emptying scan along with limited or no response or intolerance to at least 3 months of lifestyle adjustments dietary modifications and medications who will undergo G-POEM BSGM will be used to assess gastric motility before and after the procedure This design allows for the collection of data at multiple time points to assess changes in BSGM phenotypes gastroparesis symptoms and other relevant variables over time
The study team will enroll 20 participants who will undergo BSGM at baseline prior to G-POEM procedure and then again 3-6 months after G-POEM The study team plan to contact participants prior to their standard of care clinic visit to ensure participants meet eligibility criteria The study team will also explain the study over the phone using the telephone script that has been approved Appendix 1 If they are interested in the study the study team will schedule them for BSGM and go over prep instructions Once the participant arrives in clinic teh study team will consent in-person
The investigators primary objective is to evaluate the safety and feasibility BSGM in refractory gastroparesis patients undergoing G-POEM
the investigators will also investigate whether changes in BSGM measures correlate with changes in symptoms and quality of life
Additionally the investigators aim to compare the diagnostic performance of BSGM and gastric emptying scans as depicted on scintigraphy
The investigators primary aim is to assess the feasibility and safety of in gastroparesis patients undergoing G-POEM Clinical success is defined as improvement in GCSI by 1 point or more compared to baseline
The investigators will report four spectral metrics each profiling distinct features of gastric function
Body Surface Gastric Mapping Rhythm IndexTM GA-RI - a measure of gastric rhythm stability
Principal Gastric Frequency - the frequency associated with stable persistent gastric activity as defined by GA-RI
BMI-adjusted amplitude
Fed Fasted Amplitude Ratio ff-AR
Although not directly related to this outcome the investigators will continue our symptom analysis as has been previously done under the existing G-POEM protocol that includes both the pattern and severity of individual symptoms such as vomiting reflux and belching The investigators will continue to assess patient quality of life using standardized questionnaires SF-36 at baseline and 3 months post-G-POEM as is currently done with the existing protocol
This is an addition to an existing study protocol The study will involve patients with refractory gastroparesis proven on a 4-hour solid-phase gastric emptying scan along with limited or no response or intolerance to at least 3 months of lifestyle adjustments dietary modifications and medications who will undergo G-POEM BSGM will be used to assess gastric motility before and after the procedure This design allows for the collection of data at multiple time points to assess changes in BSGM phenotypes gastroparesis symptoms and other relevant variables over time
The study team will enroll 20 participants who will undergo BSGM at baseline prior to G-POEM procedure and then again 3-6 months after G-POEM The study team plan to contact participants prior to their standard of care clinic visit to ensure participants meet eligibility criteria The study team will also explain the study over the phone using the telephone script that has been approved Appendix 1 If they are interested in the study the study team will schedule them for BSGM and go over prep instructions Once the participant arrives in clinic teh study team will consent in-person
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