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

NCT04724291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-09-11

Study results available
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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

Interventions

DEVICE

MAGNET

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.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Andrew C Meltzer, MD, MS · George Washington University

  • Anita Kumar, MD · George Washington University

  • Marie Borum, MD · George Washington University

  • Samuel Schueler, MD · George Washington University

  • David Cave, MD · UMass Memorial Health

  • Samuel J Kallus, MD · George Washington University School of Medicine and Health Sciences

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2022-06-10
Completion
2023-06-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724291 on ClinicalTrials.gov