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Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis

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ClinicalTrials.gov Identifier: NCT02022826
Recruitment Status : Terminated (sponsor internal decision)
First Posted : December 30, 2013
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Gastroparesis
Intervention Device: SmartPill Monitoring System
Enrollment 167
Recruitment Details Recruitment period- January 2014 March 2017; 11 academic and community centers within the US
Pre-assignment Details 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.
Arm/Group Title SmartPill Monitoring System
Hide Arm/Group Description patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Period Title: Overall Study
Started 167
Completed 139
Not Completed 28
Arm/Group Title SmartPill Monitoring System
Hide Arm/Group Description patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Overall Number of Baseline Participants 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
<=18 years
0
   0.0%
Between 18 and 65 years
154
  92.2%
>=65 years
13
   7.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 167 participants
45
(18 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
Female
131
  78.4%
Male
36
  21.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 167 participants
167
suspected gastroparesis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
167
 100.0%
1.Primary Outcome
Title Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis
Hide Description 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
Time Frame an expected average of two weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartPill Monitoring System
Hide Arm/Group Description:
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Overall Number of Participants Analyzed 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of agreement
76
(69 to 83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SmartPill Monitoring System
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of agreement
Estimated Value 76
Confidence Interval (2-Sided) 95%
69 to 83
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description Agreement 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)
Time Frame an expected average of two weeks from study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartPill Monitoring System
Hide Arm/Group Description:
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Overall Number of Participants Analyzed 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of agreement
92
(87 to 96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SmartPill Monitoring System
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter precentage of agreement
Estimated Value 92
Confidence Interval (2-Sided) 95%
87 to 96
Estimation Comments [Not Specified]
Time Frame Adverse events collected from beginning of enrollment to last patient last visits: January 2014-March 2017 (2 years and 3 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SmartPill Monitoring System
Hide Arm/Group Description patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
All-Cause Mortality
SmartPill Monitoring System
Affected / at Risk (%)
Total   2/167 (1.20%)    
Hide Serious Adverse Events
SmartPill Monitoring System
Affected / at Risk (%) # Events
Total   10/167 (5.99%)    
Blood and lymphatic system disorders   
uncontrolled high blood pressure   1/167 (0.60%)  1
Gastrointestinal disorders   
Nausea and Vomiting   4/167 (2.40%)  5
exacerbation of pre-existing condition secondary to gastroparesis   1/167 (0.60%)  1
Abdominal Pain   1/167 (0.60%)  1
capsule retention   1/167 (0.60%)  1
General disorders   
dehydration   1/167 (0.60%)  1
Death   2/167 (1.20%)  2
Musculoskeletal and connective tissue disorders   
Right Hip Replacement   1/167 (0.60%)  1
Renal and urinary disorders   
kidney translant   1/167 (0.60%)  1
Reproductive system and breast disorders   
laproscopic-assisted vaginal historectomy and right salpingo-oophorectomy   1/167 (0.60%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SmartPill Monitoring System
Affected / at Risk (%) # Events
Total   18/167 (10.78%)    
Gastrointestinal disorders   
Abdominal Pain   5/167 (2.99%)  5
Diarrhea   1/167 (0.60%)  1
Nausea   1/167 (0.60%)  1
Vomiting   2/167 (1.20%)  2
Dumping syndrome  [1]  1/167 (0.60%)  1
extreme pain and bloating  [2]  1/167 (0.60%)  1
General disorders   
Headache   1/167 (0.60%)  1
Musculoskeletal and connective tissue disorders   
Right Hip Replacement  [3]  1/167 (0.60%)  1
Nervous system disorders   
Brain Aneurysm  [4]  1/167 (0.60%)  1
facial droop, ER visit; diagnosed with Bell's palsy  [5]  1/167 (0.60%)  1
Reproductive system and breast disorders   
kidney translant  [6]  3/167 (1.80%)  4
labioplasty with bilateral simple partial vulvectomy  [7]  1/167 (0.60%)  1
Respiratory, thoracic and mediastinal disorders   
Upper Respitory Infection  [8]  2/167 (1.20%)  2
Indicates events were collected by systematic assessment
[1]
Dumping syndrome
[2]
extreme pain and bloating
[3]
body aches and arthralgia
[4]
Brain Aneurysm
[5]
facial droop, ER visit; diagnosed with Bell's palsy
[6]
pregnancy
[7]
labioplasty with bilateral simple partial vulvectomy
[8]
Upper Respiratory Infection
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michal Kedar-Datel
Organization: Medtronic
Phone: +972-4-9097952
EMail: michal.kedar-datel@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02022826    
Other Study ID Numbers: MA-501
First Submitted: December 15, 2013
First Posted: December 30, 2013
Results First Submitted: August 20, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017