Status:
COMPLETED
MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)
Lead Sponsor:
George Washington University
Conditions:
Abdominal Pain
Gastritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot and feasibility study will be first US study to determine if a magnetically controlled capsule (MCC) can effectively visualize the anatomy of the stomach like a more traditional upper endos...
Detailed Description
In the United States, upper endoscopy is frequently performed for a variety of symptoms including heartburn, bloating, nausea, burping, and epigastric pain/burning. The prevalence of these symptoms ma...
Eligibility Criteria
Inclusion
- Individuals aged ≥ 18 years with upper GI symptoms (epigastric pain/burning, bloating, heart-burn, excessive belching, nausea/vomiting, anemia, and/or weight loss) appropriate for an upper endoscopy evaluation
- Able to speak English
- Able to understand and sign consent form
- Able to undergo standard outpatient endoscopy
- Indications for traditional EGD in the next 30 days
- Low blood (Unexplained anemia)
- Blood in vomit (Hematemesis)
- Upper abdominal or chest pain
- Indigestion (Dyspepsia)
- GERD
- Suspected ulcers
- Unexplained weight loss
- Gastric Biopsy
- Other
Exclusion
- Hemodynamic shock
- Active hematemesis
- Dysphagia, swallowing disorder, Zenker's diverticulum, suspected bowel obstruction or perforation, gastroparesis, gastric outlet obstruction, Crohn's disease, prior GI tract surgery that changes the gastrointestinal anatomy (e.g., Billroth I or II, esophagectomy, gastrectomy, bariatric procedure and small intestinal resection)
- Presumed pregnant, trying to conceive or currently breastfeeding
- Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
- Expected to have Magnetic Resonance Imaging examination within 30 days
- Currently (\<12 hours) on medications that may coat the upper GI tract such as antacids or sucralfate or Maalox
- No reliable contact information--no phone, no permanent address
- ASA status of more than 3
- Implanted with a cardiac pacemaker or other implantable electronic medical device
- BMI is greater than or equal to 38
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04724291
Start Date
February 10 2021
End Date
June 10 2023
Last Update
September 11 2023
Active Locations (1)
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1
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037