NCT04605302

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: AnX Robotica Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Gastrointestinal Symptoms

Interventions

Type	Name	Description
DEVICE	MCC/MCC-T	Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract
DEVICE	Standard gastroscopy	Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum

Timeline

• Start date: 2021-02-10
• Primary completion: 2021-06-30
• Completion: 2023-03-30
• First posted: 2020-10-28
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study