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

NCT04605302 | Completed Results FDA Device

• 1 other identifier: UMASS-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure

  24-72 hour follow up phone call post EGD procedure

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

  Day of procedure

Study Arms (1)

Single Arm Tandem Study

EXPERIMENTAL

Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy

Device: MCC/MCC-T; Device: Standard gastroscopy

Interventions

MCC/MCC-T DEVICE

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

Also known as: Magnetic controlled capsule endoscopy with/without tether

Single Arm Tandem Study

Standard gastroscopy DEVICE

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

Also known as: EGD

Single Arm Tandem Study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able to provide informed consent
• 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.

You may not qualify if:

• Patient with dysphagia.
• Patient with previous intestinal surgery.
• 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.
• Female patient who is pregnant.
• Patient with implanted medical device that would be potentially affected by magnets or radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators).

Sponsors & Collaborators

• AnX Robotica Corp.: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Results Point of Contact

• Title: Anne Foley
• Organization: University of Massachusetts

anne.foley@umassmemorial.org

774-442-4098

Study Officials

• David R Cave, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient blinded to MCC results. EGD assessor blinded to MCC results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Tandem study

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 28, 2020
• Study Start: February 10, 2021
• Primary Completion: June 30, 2021
• Study Completion: March 30, 2023
• Last Updated: May 27, 2026
• Results First Posted: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)