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OpenTrials
Completed

NCT Number: NCT04605302

Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

MCC/MCC-T

Device

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

Standard gastroscopy

Device

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

Other names: EGD

Primary outcomes

  1. Compare Total Number of Lesions Identified Via MCCE Versus EGD

    Time frame: Day of EGD procedure

    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.

  2. Number of Adverse Events

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

    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.

Secondary outcomes

  1. Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure

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

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

    Time frame: Day of procedure

    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.

Sponsors and collaborators

Lead sponsor

AnX Robotica Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Oct 28, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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