Clinical trial NCT04605302: Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Symptoms
Lead sponsor: AnX Robotica Corp.
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tandem study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of lesions
timeFrame: 2 days
measure: Number of adverse events
timeFrame: 2 days
Secondary outcomes:
measure: Patient satisfaction score
timeFrame: 2 days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: David R Cave, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: