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

Compare Total Number of Lesions Identified Via MCCE Versus EGD

A count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure.

Time frame: Day of EGD procedure

Number of Adverse Events

Occurrence and severity of adverse event related to MCCE procedure versus EGD procedure. Outcomes noted in AE/SAE sections. Adverse Events were NOT collected in the Healthy Volunteer arm.

Time frame: 24-72 hour follow up phone call post EGD procedure

Secondary Outcomes

Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure

Participant acceptance of MCCE versus EGD (units on a scale, scale of 1 to 10; when 1 is the lowest and 10 is the highest score)

Time frame: 24-72 hour follow up phone call post EGD procedure

To Compare Rate of Complete Examination for the MCC and EGD Procedures

Total count of participants who were able to complete their MCC procedure, compared to a total count of participants able to complete their EGD procedure.

Time frame: Day of procedure

Data from ClinicalTrials.gov

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