Trial Outcomes & Findings for Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis (NCT NCT02022826)
NCT ID: NCT02022826
Last Updated: 2017-11-30
Results Overview
Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET \>5 hours) and the non-reference standard, gastric Emptying scintigraphy test (\>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
an expected average of two weeks from study procedure
Results posted on
2017-11-30
Participant Flow
Recruitment period- January 2014 March 2017; 11 academic and community centers within the US
medication wash out period: Subjects instructed to discontinue agents that affect intragastric acidity including proton pump inhibitors for 7 days, histamine2 receptor antagonists for 3 days and antacids for 1 day prior to study including the day of SPM ingestion.
Participant milestones
| Measure |
SmartPill Monitoring System
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SmartPill Monitoring System
n=167 Participants
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=167 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=167 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=167 Participants
|
|
Age, Continuous
|
45 years
n=167 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=167 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=167 Participants
|
|
suspected gastroparesis
|
167 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: an expected average of two weeks from study procedurePer patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET \>5 hours) and the non-reference standard, gastric Emptying scintigraphy test (\>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis
Outcome measures
| Measure |
SmartPill Monitoring System
n=152 Participants
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis
|
76 percentage of agreement
Interval 69.0 to 83.0
|
SECONDARY outcome
Timeframe: an expected average of two weeks from study procedureAgreement between Gastric emptying time of SmartPill capsule (GET\>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (\>35% = severe)
Outcome measures
| Measure |
SmartPill Monitoring System
n=143 Participants
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis
|
92 percentage of agreement
Interval 87.0 to 96.0
|
Adverse Events
SmartPill Monitoring System
Serious events: 10 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SmartPill Monitoring System
n=167 participants at risk
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
2.4%
4/167 • Number of events 5 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
General disorders
dehydration
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Blood and lymphatic system disorders
uncontrolled high blood pressure
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
exacerbation of pre-existing condition secondary to gastroparesis
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
General disorders
Death
|
1.2%
2/167 • Number of events 2 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Renal and urinary disorders
kidney translant
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
capsule retention
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Reproductive system and breast disorders
laproscopic-assisted vaginal historectomy and right salpingo-oophorectomy
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Musculoskeletal and connective tissue disorders
Right Hip Replacement
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
Other adverse events
| Measure |
SmartPill Monitoring System
n=167 participants at risk
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
5/167 • Number of events 5 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
Diarrhea
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
General disorders
Headache
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
Nausea
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/167 • Number of events 2 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
Dumping syndrome
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Reproductive system and breast disorders
kidney translant
|
1.8%
3/167 • Number of events 4 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Nervous system disorders
Brain Aneurysm
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Gastrointestinal disorders
extreme pain and bloating
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Musculoskeletal and connective tissue disorders
Right Hip Replacement
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respitory Infection
|
1.2%
2/167 • Number of events 2 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Reproductive system and breast disorders
labioplasty with bilateral simple partial vulvectomy
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
|
Nervous system disorders
facial droop, ER visit; diagnosed with Bell's palsy
|
0.60%
1/167 • Number of events 1 • Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place