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

NCT04724291 | Completed Results DMC FDA Device

• 1 other identifier: NCR191848
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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 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

Abdominal Pain; Gastritis; Gastric Ulcer; Gastric Cancer

Keywords

capsule endoscopy; EGD

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers

  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.

  90min

• Comparison to EGD in Identifying Lesions.

  The goal of this assessment was to show that MCC is non-inferior to EGD in detecting both anatomic regions and gastric mucosal lesions

  5 Days

Secondary Outcomes (2)

• Patient Preference Compared to EGD

  30 days

• Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.

  30 days

Study Arms (1)

MAGNET + EGD

OTHER

Capsule endoscopy followed by traditional endoscopy

Device: MAGNET

Interventions

MAGNET DEVICE

This study will test the accuracy of a single-use ingestible video capsule (NaviCamTM, AnX Robotica) which is remotely controlled to record images of the inside of your stomach. Participants in this research study will have symptoms for which an evaluation by a traditional tube-based endoscopy (EGD) is indicated.

MAGNET + EGD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (3)

• White 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 BACKGROUND

• Seddighzadeh 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 BACKGROUND

• Gralnek 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 BACKGROUND

Related Links

• Feasibility and Safety of magnetically controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers

MeSH Terms

Conditions

Abdominal Pain; Gastritis; Stomach Ulcer; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Limitations and Caveats

Limitation of the study included its small sample size and low number of pathologic lesions. In addition, although the GI endoscopist was blinded to the findings of the MCCE, the second physician interpreting the MCCE (physician reviewer 2) was not blinded to the interpretation of the initial MCCE operator (physician reviewer 1).

Results Point of Contact

• Title: Dr. Andrew C. Meltzer
• Organization: George Washington University

ameltzer@mfa.gwu.edu

2027412952

Study Officials

• Andrew C Meltzer, MD, MS

  George Washington University

  PRINCIPAL INVESTIGATOR

• Anita Kumar, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Marie Borum, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Samuel Schueler, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• David Cave, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

• Samuel J Kallus, MD

  George Washington University School of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: January 26, 2021
• Study Start: February 10, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2023
• Last Updated: September 11, 2023
• Results First Posted: September 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)