Trial Outcomes & Findings for Evaluation of the Gastrointestinal Manifestation of Fabry's Disease (NCT NCT02798458)
NCT ID: NCT02798458
Last Updated: 2023-03-27
Results Overview
The primary outcome of dysmotility will be the measurement of gastric emptying transit time via a SmartPill study. Delayed GET are defined as longer than 5 hours.
COMPLETED
NA
48 participants
Up to 5 hours
2023-03-27
Participant Flow
Participant milestones
| Measure |
SmartPill Test Only
All subjects will be asked to complete a SmartPill test. The SmartPill capsule is pill-shaped and about an inch long and ½ inch wide, or about the size of a vitamin pill. The receiver unit is about the size of a paperback book. The receiver gets signals from the capsule and stores the signals on a computer chip. The capsule detects the level of acidity, temperature, and pressures in your stomach and intestines and sends the information by radio wave signals to the receiver.
Smartpill: The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.
|
SmartPill and Endoscopic Mucosal Resection
An additional small group of subjects will also be asked to complete a Sigmoidoscopy (an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed. In the Endoscopy Mucosal Resection (EMR) procedure we will use an instrument called an endoscope (a lighted, flexible tube) to take a tissue sample from the rectum. This is the same type of instrument used in a routine colonoscopy
Smartpill: The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.
Endoscopic Mucosal Resection: a Sigmoidoscopy is an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed.
|
|---|---|---|
|
Smart Pill Test (1 Day)
STARTED
|
35
|
13
|
|
Smart Pill Test (1 Day)
COMPLETED
|
35
|
13
|
|
Smart Pill Test (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Endoscopic Mucosal Resection (1 Day)
STARTED
|
0
|
13
|
|
Endoscopic Mucosal Resection (1 Day)
COMPLETED
|
0
|
13
|
|
Endoscopic Mucosal Resection (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Gastrointestinal Manifestation of Fabry's Disease
Baseline characteristics by cohort
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
46.5 years
n=7 Participants
|
46.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Enzyme replacement therapy > 6 months
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Any neurologic involvement
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Peripheral nervous system involvement
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Central nervous system (serious) involvement - make clear this excludes CN
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cardiac system involvement
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Renal systemic involvement
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Dermatology systemic involvement
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ophthalmic systemic involvement
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Psychiatric systemic involvement
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Asthma systemic involvement
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Presenting age of any neurologic systemic involvement
|
7 years
n=5 Participants
|
10 years
n=7 Participants
|
9 years
n=5 Participants
|
|
Presenting age of cardiac systemic involvement
|
34 years
n=5 Participants
|
32 years
n=7 Participants
|
32.5 years
n=5 Participants
|
|
Presenting age of renal systemic involvement
|
20.5 years
n=5 Participants
|
32 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Presenting age of ophthalmic systemic involvement
|
15.5 years
n=5 Participants
|
31 years
n=7 Participants
|
24.5 years
n=5 Participants
|
|
Presenting age of psychiatric systemic involvement
|
33.5 years
n=5 Participants
|
36.5 years
n=7 Participants
|
34.5 years
n=5 Participants
|
|
Presenting age of respiratory (asthma) systemic involvement
|
20 years
n=5 Participants
|
9 years
n=7 Participants
|
19 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 hoursPopulation: Demographics
The primary outcome of dysmotility will be the measurement of gastric emptying transit time via a SmartPill study. Delayed GET are defined as longer than 5 hours.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Gastric Emptying Transit Time Measured Via SmartPill Study
|
2.9 Hours
Interval 2.5 to 3.8
|
2.8 Hours
Interval 2.2 to 3.6
|
PRIMARY outcome
Timeframe: Up to 6 hoursPopulation: Demographics
The primary outcome of dysmotility will be the measurement of small bowel transit time via a SmartPill study. Delayed SBTT are defined as longer than 6 hours.
Outcome measures
| Measure |
Female
n=27 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Small Bowel Transit Time Measured Via SmartPill Study
|
4.3 Hours
Interval 3.8 to 5.0
|
4.5 Hours
Interval 3.1 to 5.6
|
PRIMARY outcome
Timeframe: Up to 67 hoursPopulation: Demographics
The primary outcome of dysmotility will be the measurement of colonic transit time via a SmartPill study. Delayed CTT is defined as longer than 59 hours.
Outcome measures
| Measure |
Female
n=27 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Colonic Transit Time Measured Via SmartPill Study
|
38.1 Hours
Interval 20.3 to 66.8
|
21.3 Hours
Interval 14.2 to 43.4
|
SECONDARY outcome
Timeframe: Up to 4 weeksParticipants will complete several questionnaires during study participation regarding gastrointestinal symptoms (lower and upper GI). These results will be used to determine overall gastrointestinal involvement and will be correlated with transit time and histologic findings
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Dysregulated bowel habits
|
25 Participants
|
17 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Reporting chronic diarrhea
|
14 Participants
|
16 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Reporting chronic constipation
|
20 Participants
|
11 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Reporting only diarrhea
|
5 Participants
|
6 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Reporting only constipation
|
11 Participants
|
1 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Chronic abdominal pain
|
25 Participants
|
14 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Symptoms compatible with IBS
|
23 Participants
|
14 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Bloating
|
23 Participants
|
10 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Functional dyspepsia
|
26 Participants
|
13 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Dysphagia
|
2 Participants
|
0 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
nausea and vomiting
|
15 Participants
|
7 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Gastroesophageal reflux disease symptoms
|
15 Participants
|
2 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Moderate severe depression
|
4 Participants
|
0 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Moderate severe anxiety
|
18 Participants
|
13 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Unemployed by Work Productivity and Activity Impairment
|
5 Participants
|
9 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Work loss- 40% and more by Work Productivity and Activity Impairment
|
2 Participants
|
2 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Reduced productivity 40% and more by Work Productivity and Activity Impairment
|
9 Participants
|
3 Participants
|
|
Gastrointestinal Symptom Assessment and Quality of Life, Work, and Productivity Via Questionnaires
Work/productivity impairment by Work Productivity and Activity Impairment
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksOutcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Age of Symptom Start
Age of first gastrointestinal symptoms
|
15 years
Interval 0.5 to 26.5
|
10 years
Interval 6.8 to 18.0
|
|
Age of Symptom Start
Age of abdominal pain symptom start
|
25 years
Interval 10.0 to 39.5
|
10 years
Interval 9.5 to 16.0
|
|
Age of Symptom Start
Age of Diarrhea symptom start
|
16 years
Interval 7.0 to 40.0
|
10 years
Interval 0.0 to 12.0
|
|
Age of Symptom Start
Age of constipation symptom start
|
15 years
Interval 8.0 to 27.5
|
15 years
Interval 3.0 to 42.8
|
|
Age of Symptom Start
Age of nausea symptom start
|
28 years
Interval 15.0 to 49.0
|
20 years
Interval 19.0 to 25.0
|
|
Age of Symptom Start
Age of vomiting symptom start
|
13 years
Interval 13.0 to 13.0
|
20 years
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to 5 hoursPopulation: Demographics
The secondary outcome of dysmotility will be the measurement of delayed gastric emptying measured via a SmartPill study. Delayed GET are defined as longer than 5 hours.
Outcome measures
| Measure |
Female
n=27 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Delayed Gastric Emptying Measured Via SmartPill Study
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 hoursThe secondary outcome of dysmotility will be the measurement of delayed bowel transit time via a SmartPill study. Delayed SBTT are defined as longer than 6 hours.
Outcome measures
| Measure |
Female
n=27 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Delayed Small Bowel Transit Measured Via SmartPill Study
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 67 hoursPopulation: Demographics
The secondary outcome of dysmotility will be the measurement of delayed colonic transit time via a SmartPill study. Delayed CTT is defined as longer than 59 hours.
Outcome measures
| Measure |
Female
n=27 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Delayed Colonic Transit Measured Via SmartPill Study
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 67 hours, data reported over the last 4 weeksPatient reported severity of certain symptoms over the last 4 weeks on a scale of 0 to 10 (bloating, abdominal discomfort, incomplete evacuation, straining and urgency). Higher score would mean worse (more symptoms) outcome.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Symptom Severity Index
Bowel urgency
|
4 score on a scale
Interval 2.3 to 7.8
|
4 score on a scale
Interval 2.0 to 6.8
|
|
Symptom Severity Index
Bloating
|
6 score on a scale
Interval 2.3 to 8.0
|
2 score on a scale
Interval 0.0 to 4.5
|
|
Symptom Severity Index
Abdominal discomfort
|
6.5 score on a scale
Interval 3.0 to 7.0
|
4 score on a scale
Interval 2.0 to 6.0
|
|
Symptom Severity Index
Sense of incomplete evacuation
|
3.5 score on a scale
Interval 2.0 to 7.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Symptom Severity Index
Straining while defecating
|
3.5 score on a scale
Interval 2.0 to 6.8
|
1.5 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: At 67 hours, data reported over the last 7 daysPatients reported the number of complete BMs they had during the last week (minimum could be 0 and the maximum could be any number greater than 0). Higher/lower scores could be the better or worse outcome (e.g., 0 bowel movements all week would be a worse outcome but over 10 bowel movements would be worse as well), it just depends on the extent.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Symptom Frequency Assessment (SFA)
Daily bowel movements
|
1 units on a scale
Interval 1.0 to 2.0
|
2.5 units on a scale
Interval 1.0 to 4.0
|
|
Symptom Frequency Assessment (SFA)
Weekly bowel movements
|
5.5 units on a scale
Interval 3.6 to 13.5
|
16 units on a scale
Interval 10.0 to 25.0
|
SECONDARY outcome
Timeframe: At 4 weeksThe scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<7 indicates no or minimal severity, 8-14 is mild anxiety, 15-23 is moderate anxiety and 24 and worse is severe anxiety 5. Moderate-severe anxiety was defined as a score of 15 and above.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A)
|
16.5 score on a scale
Interval 12.0 to 20.0
|
16.5 score on a scale
Interval 4.0 to 18.8
|
SECONDARY outcome
Timeframe: At 4 weeksBeck's Depression Inventory (BDI): is a 21-item tool assessing the existence and severity of symptoms of depression, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV; 1994). The items correspond to symptoms of depression and are a four-point scale for each item ranging from 0 to 3. They are summed to give a single BDI score between 0-63 (where higher results reflect more severe depression). Grades are 1-10: normal, 11-16: mild mood disturbance, 17-20: borderline clinical depression, 21-30: moderate depression, 31-40: severe depression, and \>40 extreme depression 6. Moderate-severe depression was defined as a score of 21 and above.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Beck's Depression Inventory (BDI)
|
10.5 score on a scale
Interval 6.0 to 14.8
|
6.5 score on a scale
Interval 2.3 to 14.0
|
SECONDARY outcome
Timeframe: At 7 daysWork Productivity and Activity Impairment (WPAI): examines the effect of GI symptoms on loss of work time and loss of productivity. Patients indicated if they are unemployed. For employed patients, scores are presented as percentage of time lost during the last week (hours lost due to GI symptoms out of the hours that patient should have worked, excluding the time lost on participating in the study). Higher percentages indicate greater impairment. Work missed percentage, reduced productivity percentage, and work-productivity impairment percentage (combining the 2 scores) are calculated 7. We defined work/productivity impairment as either being unemployed or having lost 40% or more of work time or productivity. For employed patients, scores are presented as percentage of time lost during the last week (hours lost due to GI symptoms out of the hours that patient should have worked, excluding the time lost on participating in the study).
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Work Productivity and Activity Impairment (WPAI)
work missed (%)
|
0 percentage of time lost during the last
Interval 0.0 to 0.0
|
0 percentage of time lost during the last
Interval 0.0 to 10.8
|
|
Work Productivity and Activity Impairment (WPAI)
reduced productivity while working (%)
|
20 percentage of time lost during the last
Interval 10.0 to 50.0
|
10 percentage of time lost during the last
Interval 10.0 to 50.0
|
|
Work Productivity and Activity Impairment (WPAI)
work productivity impairment (%)
|
20 percentage of time lost during the last
Interval 10.0 to 52.1
|
10 percentage of time lost during the last
Interval 10.0 to 60.0
|
SECONDARY outcome
Timeframe: At 4 weeksIrritable bowel syndrome quality of life (IBS-QOL): Assesses bowel specific QOL. It consists of 34 items of a 5-point Likert scale. The total score is summed and then transformed to a 0-100 scale, where 0 is low QoL, and 100 is the best QoL. Different IBS-QOL items can also be categorized to eight subscale scores (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships). Note be made, that the IBS-QOL examines the effect of "bowel problems" on different aspect of QOL, and so was used to assess the effect of gut symptoms on the patients' QOL. Higher scores are better outcome.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Dysphoria sub-score
|
85.7 score on a scale
Interval 70.0 to 95.7
|
85.7 score on a scale
Interval 59.3 to 93.6
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Interference with Activity sub-score
|
57.1 score on a scale
Interval 39.3 to 71.4
|
46.4 score on a scale
Interval 30.4 to 60.7
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Body Image sub-score
|
68.8 score on a scale
Interval 53.1 to 81.3
|
87.5 score on a scale
Interval 75.0 to 100.0
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Health Worry sub-score
|
75 score on a scale
Interval 62.5 to 91.7
|
83.3 score on a scale
Interval 77.1 to 91.7
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Food avoidance sub-score
|
50 score on a scale
Interval 33.3 to 87.5
|
75 score on a scale
Interval 43.8 to 89.6
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Social reaction sub-score
|
87.5 score on a scale
Interval 71.9 to 96.9
|
84.4 score on a scale
Interval 68.8 to 98.4
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Sexual sub-score
|
100 score on a scale
Interval 68.8 to 100.0
|
100 score on a scale
Interval 78.1 to 100.0
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
Relationships sub-score
|
100 score on a scale
Interval 79.2 to 100.0
|
91.7 score on a scale
Interval 77.1 to 100.0
|
|
IBS Quality of Life (IBS QoL) and Sub-scores
IBS-QOL
|
80.2 score on a scale
Interval 61.8 to 89.0
|
81.6 score on a scale
Interval 65.1 to 87.9
|
SECONDARY outcome
Timeframe: At 7 daysBristol Stool Scale: patients indicate their last 7 days stool consistency on 1-7 visual scale. The Bristol stool scale correlates with colonic transit time. Higher scores do not indicate better or worse outcomes. It is a visual scale.
Outcome measures
| Measure |
Female
n=28 Participants
Demographics
|
Male
n=20 Participants
Demographics
|
|---|---|---|
|
Bristol Stool Scale
|
4 score on a scale
Interval 2.0 to 5.0
|
6 score on a scale
Interval 4.0 to 6.0
|
Adverse Events
SmartPill Test
Endoscopic Mucosal Resection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SmartPill Test
n=48 participants at risk
All subjects will be asked to complete a SmartPill test. The SmartPill capsule is pill-shaped and about an inch long and ½ inch wide, or about the size of a vitamin pill. The receiver unit is about the size of a paperback book. The receiver gets signals from the capsule and stores the signals on a computer chip. The capsule detects the level of acidity, temperature, and pressures in your stomach and intestines and sends the information by radio wave signals to the receiver.
Smartpill: The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.
|
Endoscopic Mucosal Resection
n=13 participants at risk
An additional small group of subjects will also be asked to complete a Sigmoidoscopy (an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed. In the Endoscopy Mucosal Resection (EMR) procedure we will use an instrument called an endoscope (a lighted, flexible tube) to take a tissue sample from the rectum. This is the same type of instrument used in a routine colonoscopy
Smartpill: The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.
Endoscopic Mucosal Resection: a Sigmoidoscopy is an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
diarrhea
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
syncope
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
ER visit
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
Fever
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
Rectal Pain
|
2.1%
1/48 • Number of events 1 • Up to 4 days
|
7.7%
1/13 • Number of events 1 • Up to 4 days
|
Additional Information
Dr. Braden Kuo and Dr. Claire-Zar-Kessler
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place