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

NCT04605302 | Completed 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)

• Number of lesions

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

  2 days

• Number of adverse events

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

  2 days

Secondary Outcomes (1)

• Patient satisfaction score

  2 days

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

Study Officials

• David R Cave, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

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: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)