N/A
N=27
Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms
Upper Gastrointestinal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT04605302 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Compare Total Number of Lesions Identified Via MCCE Versus EGD — 10; 12 # of lesions identified
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MCC/MCC-T (Device); Standard gastroscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AnX Robotica Corp.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Total Number of Lesions Identified Via MCCE Versus EGD |
10; 12 | — |
| PRIMARY Number of Adverse Events |
1; 2 | — |
| SECONDARY Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure |
8.13; 7.56 | — |
| SECONDARY To Compare Rate of Complete Examination for the MCC and EGD Procedures |
16; 16 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04605302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.