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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06854120




Registration number
NCT06854120
Ethics application status
Date submitted
25/02/2025
Date registered
3/03/2025

Titles & IDs
Public title
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
Scientific title
Body Surface Gastric Mapping in Patients with Dyspeptic Symptoms: Recordings At Baseline and on Medical Therapy
Secondary ID [1] 0 0
AK-PRO-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Functional Dyspepsia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Gastric Alimetry

Treatment - Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator


Treatment: Devices: Gastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 µV).
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
Timepoint [3] 0 0
8 weeks

Eligibility
Key inclusion criteria
* Patients 18 years of age and older
* Diagnosis of gastroparesis and/or functional dyspepsia
* Being prescribed a prokinetic agent or symptom modulator for their clinical care
* Able to undergo BSGM recording both before and during treatment
* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Under 18 years of age
* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Pregnant women
* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/08/2028
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Sydney
Recruitment postcode(s) [1] 0 0
2560 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Western Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Temple University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
North Shore Hospital, New Zealand
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Parkman, MD
Address 0 0
Temple University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Genevieve M Johnston, PhD
Address 0 0
Country 0 0
Phone 0 0
+64 9 373 7599
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06854120