N/A N=43 Diagnostic

MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)

Abdominal Pain · Gastritis · Gastric Ulcer · Gastric Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04724291 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers — 37; 39; 39; 36 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MAGNET (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: George Washington University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers	37; 39; 39; 36; 38; 39	—
PRIMARY Comparison to EGD in Identifying Lesions.	35; 5	—
SECONDARY Patient Preference Compared to EGD	31; 3; 5; 1	—
SECONDARY Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.	39; 0; 1	—

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 endoscopy (EGD). This study is designed to enroll participants who have a standard indication for an EGD and are also willing to get an MCC exam. The MCC is driven actively by a clinician unlike prior capsule endoscopes that move passively by gravity or peristalsis. Thus, a physician will be able to look more closely at areas of the stomach that might be concerning and might need further evaluation and/or treatment.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04724291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.