Clinical trial · Interventional
MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)
Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients
NCT04724291CI-TRIAL-00069488completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Pain | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Ulcer | — | UNRESOLVED | — |
| Gastritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAGNET | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MAGNET + EGD
- description
- Capsule endoscopy followed by traditional endoscopy
- interventionNames
- Device: MAGNET
Primary outcomes (2)
- measure
- Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
- timeFrame
- 90min
- description
- Show that MCCE can identify anatomic regions of stomach consistent with established quality metrics for traditional endoscopy (\>90% photo-documentation of pre-established anatomic regions). Each of the 40 MCCE results were reviewed by at least 2 physician reviewers for their ability to document the lower esophagus, Gastroesophageal junction/Z-line, and 6 gastric landmarks the cardia, fundus, body, angularis, antrum, and pylorus.
- measure
- Comparison to EGD in Identifying Lesions.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDWhite CM, Kilgore ML. PillCam ESO versus esophagogastroduodenoscopy in esophageal variceal screening: A decision analysis. J Clin Gastroenterol. 2009 Nov-Dec;43(10):975-81. doi: 10.1097/MCG.0b013e3181a7ed09. PMID 19661814
- BACKGROUNDSeddighzadeh A, Wolf AT, Parasuraman S, Shetty R, Vallurupalli N, Reddy S, Goldhaber SZ. Gastrointestinal complications after 3 months of dual antiplatelet therapy for drug-eluting stents as assessed by wireless capsule endoscopy. Clin Appl Thromb Hemost. 2009 Mar-Apr;15(2):171-6. doi: 10.1177/1076029608325545. Epub 2008 Dec 30. PMID 19117963
- BACKGROUNDGralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645. PMID 18389444