Gastric EmptyingNCT05555407
Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
A study testing Scintigraphic gastric emptying scan and Wireless patch system (WPS) in people with Gastric Emptying, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Scintigraphic gastric emptying scan and Wireless patch system (WPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.
Who cannot join
- Have had prior gastric or esophageal surgery.
- Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy).
- Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents).
- Have been recently hospitalized for complications of diabetes or have a HgbA1c > 10.
- Have severe psychological distress preventing study participation.
- Unable to read or understand the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).
- Conditions
- Gastric Emptying
- Being tested
- Scintigraphic gastric emptying scan, Wireless patch system (WPS)
- Keywords
- Scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scintigraphic gastric emptying scanDiagnostic test
Nuclear medicine scan that provides an assessment of gastric motility
Wireless patch system (WPS)Device
Wireless wearable patches applied to the abdomen after 3 small areas of the abdomen that connect to a recording device for a total of 6 days and subjects will track mealtimes, bowel movements, and sleep using an iPhone app.
| Study group | Role | What they receive |
|---|---|---|
| Wireless patch system (WPS) | Experimental | Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed. Receives: Diagnostic Test: Scintigraphic gastric emptying scan; Device: Wireless patch system (WPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject willingness to wear a wireless patch system (WPS)
Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Aug 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Lacy, Mayo Clinic
- Investigators
- Brian Lacy, PhD, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555407
- Sponsor's protocol ID
- 22-004957
- Status last verified
- Jul 2023
- First submitted
- 19 Sep 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
- ClinicalTrials.gov ID
- NCT05555407
- Acronym / sponsor ID
- 22-004957
- Conditions
- Gastric Emptying
- Keywords
- Scintigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wireless patch system (WPS) | Experimental | Diagnostic Test: Scintigraphic gastric emptying scan, Device: Wireless patch system (WPS)Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.
Key exclusion criteria (6 listed)
- Have had prior gastric or esophageal surgery.
- Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy).
- Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents).
- Have been recently hospitalized for complications of diabetes or have a HgbA1c > 10.
- Have severe psychological distress preventing study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scintigraphic gastric emptying scanNuclear medicine scan that provides an assessment of gastric motility | Diagnostic test | Wireless patch system (WPS) |
| Wireless patch system (WPS)Wireless wearable patches applied to the abdomen after 3 small areas of the abdomen that connect to a recording device for a total of 6 days and subjects will track mealtimes, bowel movements, and sleep using an iPhone app. | Device | Wireless patch system (WPS) |
Primary outcome
Subject willingness to wear a wireless patch system (WPS)
Time frame: 7 days
Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Lacy, PhD, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scintigraphic gastric emptying scan and Wireless patch system (WPS) in people with Gastric Emptying, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject willingness to wear a wireless patch system (WPS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.