Clinical trial NCT04724291: MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)
Official title: Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Gastritis
Gastric Ulcer
Gastric Cancer
Keywords: capsule endoscopy
EGD
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot and feasibility study will be first US study to determine if a magnetically controlled capsule (MCC) can effectively visualize the anatomy of the stomach like a more traditional upper endoscopy (EGD). This study is designed to enroll participants who have a standard indication for an EGD and are also willing to get an MCC exam. The MCC is driven actively by a clinician unlike prior capsule endoscopes that move passively by gravity or peristalsis. Thus, a physician will be able to look more closely at areas of the stomach that might be concerning and might need further evaluation and/or treatment.

Detailed description: In the United States, upper endoscopy is frequently performed for a variety of symptoms including heartburn, bloating, nausea, burping, and epigastric pain/burning. The prevalence of these symptoms may provide as much as 25% of a gastroenterologist's office practice. In general, the diagnostic yield of an EGD is low. Without alarm symptoms, as many as 70% of procedures are negative for significant findings. One major indication is testing for H. pylori for which EGD may be unnecessary, because H. pylori detection can be accomplished by fecal antigen testing or breath testing as accurately as biopsy and less expensively.

Investigators believe there is an opportunity to improve the risk stratification of patients that undergo endoscopy through the use of MCC. Our primary hypothesis is that MCC allows for visualization of the stomach of symptomatic patients referred from the emergency department, urgent care, and primary care settings with clinical symptoms appropriate for endoscopy. A prospective study is proposed to evaluate the feasibility, safety and accuracy of this novel diagnostic modality.

Esophagogastroduodenoscopy (EGD) is one of the most common medical procedures and indications for epigastric pain, bloating, burning, heart-burn, excessive belching, nausea, vomiting, anemia, and weight loss. Access to EGD is limited by the cost, the need for an endoscopy specialist and the need for anesthesia. Lack of access to an EGD is a health disparity associated with increased gastric cancer mortality-to-incidence ratio. A novel approach to visualization of the upper GI tract is needed to increase access to care and improve diagnostic capabilities. Magnetically controlled capsule (MCC) is the first wireless ingestible capsule endoscope that is able to be directed by operator to visualize all anatomic areas of the stomach (NaviCam™, AnX Robotica). This study will be the first US study to examine the feasibility of using MCC in patients with relevant symptoms to the stomach. The goal is to ascertain if the diagnostic capabilities of the MCC compared to EGD are comparable for symptomatic patients who have clinical indications for an EGD.

MCC offers potential advantages over traditional EGD including the ability to be performed 24 hours a day without sedation and to be performed without an endoscopist. In addition, the MCC is less invasive, does not cause discomfort, and enables the patient to pursue normal daily activities after the procedure. Non-specialist physicians can administer the MCC and interpretation can be done in real-time or asynchronously by GI specialists. The MCC may impact decisions regarding the need for hospitalization, the need for additional diagnostic testing such as biopsy, the need for additional therapeutic interventions such as endoscopic hemostasis and polypectomy, and the need for further risk stratification of disease. The eventual work-flow may be similar to that of many current diagnostic tests such as radiologic examinations. This ability to transmit images could become especially important in rural communities or in communities that have limited access to a gastroenterologist or surgeon. Incorporation of the MCC into current practice could follow a trajectory similar to that of point-of-care ultrasonography, an imaging modality in which non-radiologist physicians have become increasingly skilled and for which indications continue to expand. The American Society of Gastrointestinal Endoscopy states that credentials for capsule endoscopy should be determined independently from other endoscopic procedures such as colonoscopy, sigmoidoscopy, or any other endoscopic procedure. The American Society of Gastrointestinal Endoscopy also emphasizes sound medical training, appropriate patient selection, correct interpretation, and continued medical management for these capsule endoscopists. Capsule endoscopy requires only image interpretation and does not require procedural skill training associated with other endoscopic procedures; therefore, ED physicians, urgent care physicians, primary care doctors, and mid-level practitioners can meet these criteria with basic training.

Contraindications to the MCC are similar to contraindications for established capsule endoscopy (CE) which has been performed safely in a variety of clinical settings. The only absolute contraindication is intestinal obstruction. There is a low risk of non-natural excretion of capsules estimated at less than 1 in 100. In general, the CE procedure poses significantly less risk than traditional EGD, and multiple studies have shown that CE is well tolerated in patients with acute symptoms.

The cost of the capsule is an important factor that may affect future use in the ED and clinics. The use of MCC in the ED, urgent care and primary care can potentially lead to more patients being safely managed in an outpatient setting. MCC may be especially cost-effective if it reduces hospital admissions, need for anesthesia, missed work days or overall EGDs. Future technological developments in the MCC may allow for operator to collect biopsy samples and perform therapeutic functions.

Eligibility criteria: Inclusion Criteria:

* Individuals aged ≥ 18 years with upper GI symptoms (epigastric pain/burning, bloating, heart-burn, excessive belching, nausea/vomiting, anemia, and/or weight loss) appropriate for an upper endoscopy evaluation
* Able to speak English
* Able to understand and sign consent form
* Able to undergo standard outpatient endoscopy
* Indications for traditional EGD in the next 30 days

  * Low blood (Unexplained anemia)
  * Blood in vomit (Hematemesis)
  * Upper abdominal or chest pain
  * Indigestion (Dyspepsia)
  * GERD
  * Suspected ulcers
  * Unexplained weight loss
  * Gastric Biopsy
  * Other

Exclusion Criteria:

* Hemodynamic shock
* Active hematemesis
* Dysphagia, swallowing disorder, Zenker's diverticulum, suspected bowel obstruction or perforation, gastroparesis, gastric outlet obstruction, Crohn's disease, prior GI tract surgery that changes the gastrointestinal anatomy (e.g., Billroth I or II, esophagectomy, gastrectomy, bariatric procedure and small intestinal resection)
* Presumed pregnant, trying to conceive or currently breastfeeding
* Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
* Expected to have Magnetic Resonance Imaging examination within 30 days
* Currently (\<12 hours) on medications that may coat the upper GI tract such as antacids or sucralfate or Maalox
* No reliable contact information--no phone, no permanent address
* ASA status of more than 3
* Implanted with a cardiac pacemaker or other implantable electronic medical device
* BMI is greater than or equal to 38

Primary outcomes:
measure: Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
timeFrame: 90min
measure: Comparison to EGD in Identifying Lesions.
timeFrame: 5 Days
Secondary outcomes:
measure: Patient Preference Compared to EGD
timeFrame: 30 days
measure: Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.
timeFrame: 30 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Andrew C Meltzer, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Anita Kumar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Marie Borum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Samuel Schueler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Memorial Health
name: David Cave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University School of Medicine and Health Sciences
name: Samuel J Kallus, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645.