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

AnX Robotica Corp.27 enrolled

Overview

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.

In the US patients commonly undergo esophagogastroduodenoscopy (EGD) for upper abdominal symptoms to try to resolve whether they have gastroesophageal reflux disease or functional dyspepsia, if they are older than the age of 60 with symptoms, or have alarm symptoms such as unexplained weight loss, persistent nausea and vomiting or if they have symptoms that are refractory to acid suppression therapy. Given the increasing burden of digestive disease in the US, the use of EGD is increasing in volume nationwide. EGD usually requires either conscious sedation or monitored anesthesia sedation, which has put an additional cost burden on the healthcare system. Since MCC or MCC-T does not require sedation, it offers an attractive option for both patients and clinicians alike. The aim of this study is to compare in the same patient the accuracy of the MCC and MCC-T and EGD in patients presenting with upper abdominal symptoms.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Upper Gastrointestinal Symptoms

Interventions

MCC/MCC-TDEVICE

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

Standard gastroscopyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is able to provide informed consent 2. Patient has appropriate indications for EGD including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain. Exclusion Criteria: 1. Patient with dysphagia. 2. Patient with previous intestinal surgery. 3. Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent CTE, MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule. 4. Female patient who is pregnant. 5. Patient with implanted medical device that would be potentially affected by magnets or radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators).

Locations (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Number of lesions

Number of lesions found by MCC/MCC-T versus EGD

Time frame: 2 days

Number of adverse events

Occurrence and severity of adverse event related to MCC/MCC-T procedure versus EGD procedure

Time frame: 2 days

Secondary Outcomes

Patient satisfaction score

Patient acceptance of MCC/MCC-T versus EGD (scale of 1 to 10 when 1 is the lowest and 10 is the highest score)

Time frame: 2 days

Data from ClinicalTrials.gov

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