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

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ClinicalTrials.gov Identifier: NCT04605302
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Symptoms Device: MCC/MCC-T Device: Standard gastroscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Tandem study
Masking: None (Open Label)
Masking Description: Patient blinded to MCC results. EGD assessor blinded to MCC results.
Primary Purpose: Diagnostic
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
Estimated Study Start Date : February 12, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Single Arm Tandem Study
Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy
Device: MCC/MCC-T
Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract
Other Name: Magnetic controlled capsule endoscopy with/without tether

Device: Standard gastroscopy
Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum
Other Name: EGD




Primary Outcome Measures :
  1. Number of lesions [ Time Frame: 2 days ]
    Number of lesions found by MCC/MCC-T versus EGD

  2. Number of adverse events [ Time Frame: 2 days ]
    Occurrence and severity of adverse event related to MCC/MCC-T procedure versus EGD procedure


Secondary Outcome Measures :
  1. Patient satisfaction score [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605302


Contacts
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Contact: Anne Foley 7744424098 anne.foley@umassmemorial.org
Contact: David R Cave, MD, PhD 7744424098 david.cave@umassmemorial.org

Locations
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United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Anne Foley    774-442-4098    anne.foley@umassmemorial.org   
Principal Investigator: David R Cave, MD, PhD         
Sponsors and Collaborators
AnX Robotica Corp.
Investigators
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Principal Investigator: David R Cave, MD, PhD University of Massachusetts, Worcester
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Responsible Party: AnX Robotica Corp.
ClinicalTrials.gov Identifier: NCT04605302    
Other Study ID Numbers: UMASS-01
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No