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Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms

NCT04605302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-04-04

No results posted yet for this study

Summary

A prospective single blinded, tandem study, comparing a magnetically controlled capsule with or without a tether (MCC or MCC-T) with conventional upper endoscopy for the diagnosis of patients with upper abdominal symptoms.

Conditions

  • Upper Gastrointestinal Symptoms

Interventions

DEVICE

MCC/MCC-T

Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract

DEVICE

Standard gastroscopy

Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum

Sponsors & Collaborators

  • AnX Robotica Corp.

    lead INDUSTRY

Principal Investigators

  • David R Cave, MD, PhD · University of Massachusetts, Worcester

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2021-06-30
Completion
2023-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04605302 on ClinicalTrials.gov