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A shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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The purpose of this study is to demonstrate the feasibility of using the transnasal endomicroscopy (TNE) platform, using intestinal potential difference (IPD) and microbiome brush to evaluate the intestine of unsedated infants.
A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study.
While the subject is awake and unseated, a catheter with optical coherence tomography (OCT) imaging technology will be introduced transnasally. Images will be acquired while the tube is moved through the subject's GI tract. After imaging is complete, accessory device(s) may be threaded through the catheter to collect samples of the gut microbiome and/or measure intestinal potential difference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans Nasal Endomicroscopy Imaging | Experimental | The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transnasal introduction tube | Device | Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Acquire Intestinal Images in an Unsedated Infant | Can the technology successfully collect images of the small intestine in an unseated infant? | Approximate 90 minute study visit |
| Ability for Unsedated Infant Subjects to Tolerate the Device | Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort? | Approximate 90 minute study visit |
| Ability to Visualize Features of the Small Intestine in Unsedated Infants. | Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants? | Approximate 90 minute study visit |
| Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples | Can the technology successfully collect microbiome brush and/or intestinal potential differences samples? | Approximate 90 minute study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants | Measurements including DNA load and microbial composition will be collected. | Approximate 90 minute study visit |
| Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants |
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Inclusion Criteria:
Exclusion Criteria:
Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube
Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter.
Any infants with absolute or relative contraindications to transnasal tubes:
Any infant with absolute or relative contraindication to a duodenal biopsy:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Children's Hospital | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trans Nasal Endomicroscopy Imaging | The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit. Transnasal introduction tube: Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Trans Nasal Endomicroscopy Imaging | The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit. Transnasal introduction tube: Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Ability to Acquire Intestinal Images in an Unsedated Infant | Can the technology successfully collect images of the small intestine in an unseated infant? | Procedure was terminated early due to loss of the imaging signal, therefore no OCT images of the small intestines were acquired for this subject, thus this participant could not be assessed for this outcome measure. | Posted | Approximate 90 minute study visit |
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The duration of the imaging procedure (approximate 90 minute study visit) and post visit follow up phone call, the following day.
No adverse event has been reported
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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 | Trans Nasal Endomicroscopy Imaging | The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit. Transnasal introduction tube: Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Tearney, MD, PhD | Massachusetts General Hospital | 617-724-2979 | gtearney@mgb.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 3, 2023 | Jan 30, 2025 | Prot_SAP_000.pdf |
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Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants |
| Approximate 90 minute study visit |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Ability for Unsedated Infant Subjects to Tolerate the Device | Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort? | The procedure was tolerated by the study participant during insertion, imaging of the stomach and removal of the TNIT but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Tolerability could not be assessed for some portions of the study procedure including transit to the small intestine, IPD measurements and microbiome brush sample collection. | Posted | Count of Participants | Participants | Approximate 90 minute study visit |
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| Primary | Ability to Visualize Features of the Small Intestine in Unsedated Infants. | Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants? | OCT images were acquired through the TNIT from the esophagus and stomach but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Features of the small intestine (villi etc) could not be assessed. | Posted | Approximate 90 minute study visit |
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| Primary | Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples | Can the technology successfully collect microbiome brush and/or intestinal potential differences samples? | The procedure was terminated early and target samples were not collected in the enrolled subject. Subsequently, a shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled. | Posted | Approximate 90 minute study visit |
|
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| Secondary | Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants | Measurements including DNA load and microbial composition will be collected. | The procedure was terminated early and target samples were not collected in the enrolled subject. Subsequently, a shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled. | Posted | Approximate 90 minute study visit |
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| Secondary | Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants | Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants | The procedure was terminated early prior to the TNIT entering the small intestine due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant and IPD measurements were not collected. | Posted | Approximate 90 minute study visit |
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