Trial Outcomes & Findings for Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at UVa (NCT NCT05857488)
NCT ID: NCT05857488
Last Updated: 2025-08-08
Results Overview
Can the technology successfully collect images of the small intestine in an unseated infant?
TERMINATED
NA
1 participants
Approximate 90 minute study visit
2025-08-08
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at UVa
Baseline characteristics by cohort
| Measure |
Trans Nasal Endomicroscopy Imaging
n=1 Participants
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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|---|---|
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Age, Categorical
<=18 years
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1 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
|
27 Months
STANDARD_DEVIATION 0 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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1 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Can the technology successfully collect images of the small intestine in an unseated infant?
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Outcome measures
| Measure |
Trans Nasal Endomicroscopy Imaging
n=1 Participants
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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|---|---|
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Ability for Unsedated Infant Subjects to Tolerate the Device
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1 Participants
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PRIMARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants?
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Measurements including DNA load and microbial composition will be collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximate 90 minute study visitPopulation: 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.
Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants
Outcome measures
Outcome data not reported
Adverse Events
Trans Nasal Endomicroscopy Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Guillermo Tearney, MD, PhD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place