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

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Symptoms
• Interventions: Device: MCC/MCC-T; Device: Standard gastroscopy

• Registration Number: NCT04605302
• Lead Sponsor: AnX Robotica Corp.

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.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Study Start: 2021-02-10
• Primary Completion: 2021-06-30
• Status Verified: 2023-03
• Study Completion: 2023-03-30
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Tandem Study	MCC/MCC-T	Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy
Single Arm Tandem Study	Standard gastroscopy	Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States