Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

NCT05004012 | Completed Results FDA Device

• 1 other identifier: IRB#20-001573
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia

Conditions

Dyspepsia; Gastroparesis

Outcome Measures

Primary Outcomes (4)

• Frequency of Contractions at Baseline

  Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).

  Comparison between stomach contractions at baseline (Stage 1/ before sham meal)

• Largest Diameter of the Pylorus

  Physiologic parameter measuring the diameter of the pylorus

  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.

  Assessed at baseline.

• Number of Participants With Procedure Related Adverse Events

  Procedure related adverse events during or after the study session

  Through participants' study participation, approximately 1 day

Other Outcomes (1)

• Number and Location of Luminal Transit Markers in the Antrum, Fundus, and Overall

  Through study completion, an average of 1 year

Study Arms (4)

Control

OTHER

No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM

Device: Magnetically Controlled Capsule Endoscopy

Gastroparesis

OTHER

Patients with a diagnosis of gastroparesis meeting the inclusion criteria

Device: Magnetically Controlled Capsule Endoscopy

Functional Dyspepsia

OTHER

Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria

Device: Magnetically Controlled Capsule Endoscopy

G-POEM

OTHER

Patients who received a G-POEM procedure meeting the inclusion criteria

Device: Magnetically Controlled Capsule Endoscopy

Interventions

Magnetically Controlled Capsule Endoscopy DEVICE

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.

Control; Functional Dyspepsia; G-POEM; Gastroparesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• 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.

  PMID: 22591037 BACKGROUND

• Camilleri 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.

  PMID: 23147521 BACKGROUND

• Revicki 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.

  PMID: 12848636 BACKGROUND

• Revicki 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.

  PMID: 15354277 BACKGROUND

• Carbone 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.

  PMID: 31394286 BACKGROUND

MeSH Terms

Conditions

Gastroparesis; Dyspepsia

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Lin Chang MD (PI), regan cortessis (study coordinator)
• Organization: UCLA

linchang@mednet.ucla.edu, rcortessis@mednet.ucla.edu

310-206-1656

Study Officials

• Lin Chang, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: August 13, 2021
• Study Start: December 1, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)