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 |
|---|---|---|
| Compare Total Number of Lesions Identified Via MCCE Versus EGD | Day of EGD procedure | A count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure. |
| Number of Adverse Events | 24-72 hour follow up phone call post EGD procedure | Occurrence and severity of adverse event related to MCCE procedure versus EGD procedure. Outcomes noted in AE/SAE sections. Adverse Events were NOT collected in the Healthy Volunteer arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure | 24-72 hour follow up phone call post EGD procedure | Participant acceptance of MCCE versus EGD (units on a scale, scale of 1 to 10; when 1 is the lowest and 10 is the highest score) |
| To Compare Rate of Complete Examination for the MCC and EGD Procedures | Day of procedure | Total count of participants who were able to complete their MCC procedure, compared to a total count of participants able to complete their EGD procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid R Cave, MD, PhD
University of Massachusetts, Worcester
Participant flow
Recruitment details
11 healthy volunteers had the MCCE procedure for training purposes only, they did not have the EGD procedure; demographic data was collected, however outcome data was not collected or analyzed
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.56 years STANDARD_DEVIATION 11.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Population | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed