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

A Prospective Single Blinded, Pilot 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

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Symptoms
• Intervention / Treatment: Device: MCC/MCC-T; Device: Standard gastroscopy

Detailed Description

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
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm Tandem Study; Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy	Device: MCC/MCC-T; Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract; Other Names: Magnetic controlled capsule endoscopy with/without tether; Device: Standard gastroscopy; Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum; Other Names: EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24-72 hour follow up phone call post EGD procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Day of procedure

Collaborators and Investigators

• Sponsor: AnX Robotica Corp.
• Investigators: Principal Investigator: David R Cave, MD, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UMASS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No