CompletedNot Applicable

Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

United States20 participantsStarted 2021-12-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Frequency of Contractions at Baseline

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

Largest Diameter of the Pylorus

Timeframe: assessed after the sham meal (stage II, completed within 2 hours of baseline)

Dyspepsia Severity Scale Symptom Ratings at Baseline.

Timeframe: Assessed at baseline.

Number of Participants With Procedure Related Adverse Events

Timeframe: Through participants' study participation, approximately 1 day

Trial details

NCT IDNCT05004012

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-22

Results submitted2024-04-09

View on ClinicalTrials.gov More Gastroparesis trials