CompletedNot Applicable

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

United States27 participantsStarted 2021-02-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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).

What they're measuring

Number of lesions

Timeframe: 2 days

Number of adverse events

Timeframe: 2 days

Trial details

NCT IDNCT04605302

SponsorAnX Robotica Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Upper Gastrointestinal Symptoms trials