Upper Gastrointestinal Symptoms
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEMCC/MCC-T
Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract
DEVICEStandard gastroscopy
Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum
Sponsors
AnX Robotica Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Patient blinded to MCC results. EGD assessor blinded to MCC results.
Intervention model description
Tandem study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions | 2 days | Number of lesions found by MCC/MCC-T versus EGD |
| Number of adverse events | 2 days | Occurrence and severity of adverse event related to MCC/MCC-T procedure versus EGD procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 2 days | Patient acceptance of MCC/MCC-T versus EGD (scale of 1 to 10 when 1 is the lowest and 10 is the highest score) |
Countries
United States
Outcome results
None listed