GastroparesisNCT05004012
Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
A study of Gastroparesis and Dyspepsia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Dyspepsia
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 22 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must meet one of the following categories:
- Gastroparesis
- Meets diagnostic criteria for gastroparesis:
- Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam
- Absence of mechanical obstruction
- Exhibits cardinal symptoms of early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain
Show all 23Show fewer
- Gastrointestinal cardinal symptom index (GCSI) score > 0 (i.e., the presence of at least mild severity of >1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating).
- Functional Dyspepsia
- Meets Rome IV diagnostic criteria for functional dyspepsia:
- Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis
- No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy)
- Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome
- Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week
- Bothersome epigastric pain
- Bothersome epigastric burning
- Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week
- Bothersome postprandial fullness
- Bothersome early satiation
- G-POEM
- The G-POEM procedure must have been performed at least 4 weeks prior to screening.
- GCSI score is < 3 which correlates to mild or less symptom severity.
- Controls
- None of the above conditions
Who cannot join
- Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics).
- Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects.
- Dysphagia, swallowing disorder
- Suspected bowel obstruction or perforation
- Gastric or parenteral feeding within 4 weeks of screening
- Pregnancy or nursing
Show all 23Show fewer
- History of an eating disorder within 2 years of screening
- Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5.
- Uncontrolled thyroid disease
- Unstable cardiac, respiratory, hepatic or renal disease
- Evidence of uncontrolled blood glucose (including HbA1C >9 or metabolic crisis in past 60 days).
- Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 1 month prior to the screening visit).
- Use of as needed or daily opioids within the past 1 month.
- Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening visit.
- Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
- Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days.
- No reliable contact information - no phone, no permanent address.
- Pacemaker or ICD
- Inability to avoid using the bathroom for urination and/or bowel movements for the duration of the study.
- Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent)
- Prior bowel surgery
- Severe claustrophobia
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: AnX/Ankon Navicam Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia
Read the detailed description
Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.
- Conditions
- Gastroparesis, Dyspepsia
- Being tested
- Magnetically Controlled Capsule Endoscopy
- Medical subject headings
- Gastroparesis, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically Controlled Capsule EndoscopyDevice
This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM Receives: Device: Magnetically Controlled Capsule Endoscopy |
| Gastroparesis | Other | Patients with a diagnosis of gastroparesis meeting the inclusion criteria Receives: Device: Magnetically Controlled Capsule Endoscopy |
| Functional Dyspepsia | Other | Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria Receives: Device: Magnetically Controlled Capsule Endoscopy |
| G-POEM | Other | Patients who received a G-POEM procedure meeting the inclusion criteria Receives: Device: Magnetically Controlled Capsule Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Contractions at Baseline
Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).
Measured: Comparison between stomach contractions at baseline (Stage 1/ before sham meal)
Largest Diameter of the Pylorus
Physiologic parameter measuring the diameter of the pylorus
Measured: assessed after the sham meal (stage II, completed within 2 hours of baseline)
Dyspepsia Severity Scale Symptom Ratings at Baseline.
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20; with higher scores indicating more severe symptoms of dyspepsia) at baseline.
Measured: Assessed at baseline.
Number of Participants With Procedure Related Adverse Events
Procedure related adverse events during or after the study session
Measured: Through participants' study participation, approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chang, MD, University of California, Los Angeles
- Investigators
- Lin Chang, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004012
- Sponsor's protocol ID
- IRB#20-001573
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2021
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lacy BE, Talley NJ, Locke GR 3rd, Bouras EP, DiBaise JK, El-Serag HB, Abraham BP, Howden CW, Moayyedi P, Prather C. Review article: current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther. 2012 Jul;36(1):3-15. doi: 10.1111/j.1365-2036.2012.05128.x. Epub 2012 May 16.
PubMed 22591037Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
PubMed 23147521Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
PubMed 12848636Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
PubMed 15354277Carbone F, Vanuytsel T, Tack J. Analysis of Postprandial Symptom Patterns in Subgroups of Patients With Rome III or Rome IV Functional Dyspepsia. Clin Gastroenterol Hepatol. 2020 Apr;18(4):838-846.e3. doi: 10.1016/j.cgh.2019.07.053. Epub 2019 Aug 5.
PubMed 31394286
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AnX/Ankon Navicam Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
- ClinicalTrials.gov ID
- NCT05004012
- Acronym / sponsor ID
- IRB#20-001573
- Conditions
- Gastroparesis, Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia
Detailed description
Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: Magnetically Controlled Capsule EndoscopyNo diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM |
| Gastroparesis | Other | Device: Magnetically Controlled Capsule EndoscopyPatients with a diagnosis of gastroparesis meeting the inclusion criteria |
| Functional Dyspepsia | Other | Device: Magnetically Controlled Capsule EndoscopyPatients with a diagnosis of functional dyspepsia meeting the inclusion criteria |
| G-POEM | Other | Device: Magnetically Controlled Capsule EndoscopyPatients who received a G-POEM procedure meeting the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Gastroparesis
- Gastrointestinal cardinal symptom index (GCSI) score > 0 (i.e., the presence of at least mild severity of >1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating).
- Functional Dyspepsia
- Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week
- Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week
Key exclusion criteria (23 listed)
- Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics).
- Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects.
- Dysphagia, swallowing disorder
- Suspected bowel obstruction or perforation
- Gastric or parenteral feeding within 4 weeks of screening
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 |
|---|---|---|
| Magnetically Controlled Capsule EndoscopyThis is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility. | Device | Control, Functional Dyspepsia, G-POEM, Gastroparesis |
Primary outcome
Frequency of Contractions at Baseline
Time frame: Comparison between stomach contractions at baseline (Stage 1/ before sham meal)
Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).
Largest Diameter of the Pylorus
Time frame: assessed after the sham meal (stage II, completed within 2 hours of baseline)
Physiologic parameter measuring the diameter of the pylorus
Dyspepsia Severity Scale Symptom Ratings at Baseline.
Time frame: Assessed at baseline.
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20; with higher scores indicating more severe symptoms of dyspepsia) at baseline.
Number of Participants With Procedure Related Adverse Events
Time frame: Through participants' study participation, approximately 1 day
Procedure related adverse events during or after the study session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22591037Lacy BE, Talley NJ, Locke GR 3rd, Bouras EP, DiBaise JK, El-Serag HB, Abraham BP, Howden CW, Moayyedi P, Prather C. Review article: current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther. 2012 Jul;36(1):3-15. doi: 10.1111/j.1365-2036.2012.05128.x. Epub 2012 May 16.
- Background: PubMed 23147521Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
- Background: PubMed 12848636Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
- Background: PubMed 15354277Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
- Background: PubMed 31394286Carbone F, Vanuytsel T, Tack J. Analysis of Postprandial Symptom Patterns in Subgroups of Patients With Rome III or Rome IV Functional Dyspepsia. Clin Gastroenterol Hepatol. 2020 Apr;18(4):838-846.e3. doi: 10.1016/j.cgh.2019.07.053. Epub 2019 Aug 5.
- 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.
Lin Chang, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gastroparesis and Dyspepsia, run by University of California, Los Angeles 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 23 inclusion and 23 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 29 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Contractions at Baseline (time frame: Comparison between stomach contractions at baseline (Stage 1/ before sham meal)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004012, which also lists 5 linked publications.
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 29 Apr 2026.