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

 1. Patient is able to provide informed consent

 2. 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:

 1. Patient with dysphagia.

 2. Patient with previous intestinal surgery.

 3. 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.

 4. Female patient who is pregnant.

 5. Patient with implanted medical device that would be potentially affected by magnets or
 radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators).