Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411574
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-28
Brief Title:
Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis
Sponsor:
University of Western Sydney
Organization:
University of Western Sydney
Study Overview
Official Title:
Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
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:
None
Brief Summary:
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life psychological distress frequent hospitalisations and high healthcare utilization and associated costs It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction Gastric emptying scintigraphy GES is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned Current management strategies have often been found to be ineffective largely due to an incomplete understanding of the diseases pathophysiology There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy
Body surface gastric mapping BSGM using Gastric Alimetry Alimetry Ltd New Zealand is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts including patients with nausea and vomiting disorders diabetes delayed gastric emptying and post-gastric surgery Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES 43 vs 23 Clinical application of these phenotypes has also aided in changing management decisions which reduced healthcare utilization and associated costs However how GES and BSGM test results differentially influence clinical management in patients is uncertain
This exploratory pilot study proposes a two-arm prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care GES in patients with suspected gastroparesis The trial consists of two phases Phase 1 involves participants separately undertaking a GES and BSGM test Based on these results the referring clinician will devise management plans for treatment using a standardized form 1 unblinded to one test GES or BSGM but blinded to the other test and 2 unblinded to both tests GES BSGM They will be asked to recommend any changes to interventions medications diet endoscopicsurgical referral or other and additional testing In phase 2 those in Phase 1 will undergo BSGM-guided care based on their combined management plan GES BSGM and followed up over a 12 month period A separate set of participants will be recruited to undergo standard of care GES only in parallel with Phase 1 participants After 12 months those on the standard of care arm will be crossed over to BSGM-guided care undergo a BSGM test treated according to the new management plan and followed up over 6 months Questionnaires will assess symptoms quality of life health psychology sleep and work impact
If validated this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach
Body surface gastric mapping BSGM using Gastric Alimetry Alimetry Ltd New Zealand is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts including patients with nausea and vomiting disorders diabetes delayed gastric emptying and post-gastric surgery Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES 43 vs 23 Clinical application of these phenotypes has also aided in changing management decisions which reduced healthcare utilization and associated costs However how GES and BSGM test results differentially influence clinical management in patients is uncertain
This exploratory pilot study proposes a two-arm prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care GES in patients with suspected gastroparesis The trial consists of two phases Phase 1 involves participants separately undertaking a GES and BSGM test Based on these results the referring clinician will devise management plans for treatment using a standardized form 1 unblinded to one test GES or BSGM but blinded to the other test and 2 unblinded to both tests GES BSGM They will be asked to recommend any changes to interventions medications diet endoscopicsurgical referral or other and additional testing In phase 2 those in Phase 1 will undergo BSGM-guided care based on their combined management plan GES BSGM and followed up over a 12 month period A separate set of participants will be recruited to undergo standard of care GES only in parallel with Phase 1 participants After 12 months those on the standard of care arm will be crossed over to BSGM-guided care undergo a BSGM test treated according to the new management plan and followed up over 6 months Questionnaires will assess symptoms quality of life health psychology sleep and work impact
If validated this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach
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?:
False
Is an FDA AA801 Violation?:
None