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

Participant Flow

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
Arm/Group Description	patients with symptoms of Gastropar...
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

Baseline Characteristics

Arm/Group Title		SmartPill Monitoring System
Arm/Group Description		patients with symptoms of Gastropar...
Arm/Group Description		patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Overall Number of Baseline Participants		167
Baseline Analysis Population Description		[Not Specified]
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
United States		167
suspected gastroparesis Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	167 participants
		167 100.0%

Outcome Measures

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
Description	Per patient device agreement for the diagnosis of delayed gastric empt...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SmartPill Monitoring System
Arm/Group Description:	patients with symptoms of Gastropar...
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)

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
Description	Agreement between Gastric emptying time of SmartPill capsule (GET>8...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	SmartPill Monitoring System
Arm/Group Description:	patients with symptoms of Gastropar...
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)

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]

Adverse Events

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
Arm/Group Description	patients with symptoms of Gastropar...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee AA, Rao K, Parkman HP, McCallum RW, Sarosiek I, Nguyen LA, Wo JM, Schulman MI, Moshiree B, Rao S, Kuo B, Hasler WL. Baseline Predictors of Longitudinal Changes in Symptom Severity and Quality of Life in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2020 Sep 21. pii: S1542-3565(20)31293-3. doi: 10.1016/j.cgh.2020.09.032. [Epub ahead of print]

Hasler WL, Rao SSC, McCallum RW, Krause RA, Nguyen LA, Schulman MI, Lee AA, Moshiree B, Wo JM, Parkman HP, Sarosiek I, Wilding GE, Kuo B. Influence of Gastric Emptying and Gut Transit Testing on Clinical Management Decisions in Suspected Gastroparesis. Clin Transl Gastroenterol. 2019 Oct;10(10):e00084. doi: 10.14309/ctg.0000000000000084.

Lee AA, Rao S, Nguyen LA, Moshiree B, Sarosiek I, Schulman MI, Wo JM, Parkman HP, Wilding GE, McCallum RW, Hasler WL, Kuo B. Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1770-1779.e2. doi: 10.1016/j.cgh.2018.11.063. Epub 2018 Dec 14.

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

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