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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Tandem Study | Experimental | Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCC/MCC-T | Device | Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Total Number of Lesions Identified Via MCCE Versus EGD | A count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure. | Day of EGD procedure |
| Number of Adverse Events | Occurrence and severity of adverse event related to MCCE procedure versus EGD procedure. Outcomes noted in AE/SAE sections. Adverse Events were NOT collected in the Healthy Volunteer arm. | 24-72 hour follow up phone call post EGD procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure | Participant acceptance of MCCE versus EGD (units on a scale, scale of 1 to 10; when 1 is the lowest and 10 is the highest score) | 24-72 hour follow up phone call post EGD procedure |
| To Compare Rate of Complete Examination for the MCC and EGD Procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Cave, MD, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
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11 healthy volunteers had the MCCE procedure for training purposes only, they did not have the EGD procedure; demographic data was collected, however outcome data was not collected or analyzed
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Tandem Procedures | Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD). |
| FG001 | Healthy Volunteers | Healthy volunteers received the MCC procedure only for training purposes. Demographic data was collected, but they did not have the EGD procedure and there is no outcome data or analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants had MCCE procedure followed by an EGD procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Tandem Procedures | Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD). |
| BG001 | Healthy Volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compare Total Number of Lesions Identified Via MCCE Versus EGD | A count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure. | Posted | Number | # of lesions identified | Day of EGD procedure |
|
Participants were followed in this study for 24-72 hours post the EGD procedure. Any open AEs to be followed by the prescribing physician.
subcategories = mild vs moderate vs severe
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Tandem Procedures | Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD). Healthy volunteers assisted with physician training and received the capsule endoscopy only, they did not have the EGD procedure. Healthy volunteers were NOT followed for Adverse Event or Follow-up Data. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal cramping with MCCE procedure | Gastrointestinal disorders | study protocol | Systematic Assessment | mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Foley | University of Massachusetts | 774-442-4098 | anne.foley@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2022 | Feb 5, 2025 | Prot_SAP_002.pdf |
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Tandem study
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Patient blinded to MCC results. EGD assessor blinded to MCC results.
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|
| Standard gastroscopy | Device | Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum |
|
|
Total count of participants who were able to complete their MCC procedure, compared to a total count of participants able to complete their EGD procedure. |
| Day of procedure |
Healthy volunteers had the MCC procedure for training purposes only. Demographics data was captured, but follow up data was not recorded and outcome data was not analyzed.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Population | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Number of Adverse Events | Occurrence and severity of adverse event related to MCCE procedure versus EGD procedure. Outcomes noted in AE/SAE sections. Adverse Events were NOT collected in the Healthy Volunteer arm. | interventional group | Posted | Number | events | 24-72 hour follow up phone call post EGD procedure |
|
|
|
| Secondary | Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure | Participant acceptance of MCCE versus EGD (units on a scale, scale of 1 to 10; when 1 is the lowest and 10 is the highest score) | Participants who received both MCCE and EGD | Posted | Mean | Standard Deviation | units on a scale | 24-72 hour follow up phone call post EGD procedure |
|
|
|
| Secondary | To Compare Rate of Complete Examination for the MCC and EGD Procedures | Total count of participants who were able to complete their MCC procedure, compared to a total count of participants able to complete their EGD procedure. | All 16 participants completed both the MCC and the EGC procedure. | Posted | Number | participants | Day of procedure |
|
|
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| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
|
| vomiting with EGD procedure | Gastrointestinal disorders | study protocol | Systematic Assessment | mild |
|
| acid reflux with EGD procedure | Gastrointestinal disorders | study protocol | Systematic Assessment | mild |
|
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