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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Upper Gastrointestinal Symptoms

Intervention / Treatment
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* Device: MCC/MCC-T
* Device: Standard gastroscopy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Tandem study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Tandem Study<br>Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy | Device: MCC/MCC-T<br>* Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract<br>* Other names: Magnetic controlled capsule endoscopy with/without tether;Device: Standard gastroscopy<br>* Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum<br>* Other names: EGD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction score | Patient acceptance of MCC/MCC-T versus EGD (scale of 1 to 10 when 1 is the lowest and 10 is the highest score) | 2 days |