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

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02022826
• Collaborator: (none)
• Enrollment: 167
• Locations: 11
• Arm: 1
• Duration (Months): 37.9
• Patients Per Site: 15.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited.

Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Device: SmartPill Monitoring System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SmartPill Monitoring System patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test	Device: SmartPill Monitoring System; Other Names: SPM

Outcome Measures

Primary Outcome Measures

1. Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis [an expected average of two weeks from study procedure]

   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

Secondary Outcome Measures

1. 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 [an expected average of two weeks from study procedure]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks.

• Presenting with 2 or more of the following symptoms or signs which, in the opinion of the site investigator, are suggestive of a diagnosis of gastroparesis:

• 1 Nausea, vomiting, or retching (dry heaves)

• 2 Postprandial fullness or early satiety

• 3 Bloating or visible abdominal distention

• 4 Postprandial discomfort or pain

• Ability to stop proton pump inhibitors for 7 days and histamine2 receptor antagonists, prokinetic agents, narcotic agents, anticholinergic drugs, and cannabinoids 3 days prior to SPM and gastric scintigraphy testing.

• No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes [hemoglobin A1c >10% within the past 6 months], electrolyte imbalance).

• An upper endoscopy or upper gastrointestinal barium series within the past 2 years showing no organic disease that is potentially causative of symptoms.

• High probability of compliance and completion of study.

Exclusion Criteria:

• Participation in previous SmartPill clinical trials.

• Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).

• Dysphagia to solid food or pills.

• Prior surgery involving the luminal gastrointestinal tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed > 3 months prior to SPM test).

• Any abdominal or pelvic surgery within the past 3 months

• Known or history of inflammatory bowel disease.

• History of diverticulitis, diverticular stricture, and other intestinal strictures.

• Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)

• Tobacco or alcohol use within eight hours prior to capsule ingestion.

• BMI > 40 kg/m2.

• Allergies to eggs, bread, or jam.

• Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (Urine pregnancy testing will be performed on female subjects of child-bearing potential prior to capsule ingestion and gastric scintigraphy).

• Use of cardiac medical devices such as pacemakers and defibrillators (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).

• Uncontrolled diabetes with a hemoglobin A1c >10%.

• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305
2	Florida Digestive Health	Largo	Florida	United States	33777
3	Miami miller school of Medicin	Miami	Florida	United States
4	Georgia Regents University	Augusta	Georgia	United States	30909
5	Indiana University	Indianapolis	Indiana	United States	46202
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	Temple University	Philadelphia	Pennsylvania	United States	19140
9	Clinsearch,LLC	Chattanooga	Tennessee	United States	37421
10	Texas Tech University	El Paso	Texas	United States	79905
11	Fletcher Allen Health Care	Burlington	Vermont	United States	05401

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Braden Kuo, Dr.,

Study Documents (Full-Text)

• Study Protocol - Mar 15, 2015
• Statistical Analysis Plan - Jan 5, 2017

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02022826
• Other Study ID Numbers: MA-501
• First Posted: Dec 30, 2013
• Last Update Posted: Nov 30, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Medtronic - MITG: Gastroparesis; SmartPill Monitoring System (SPM); Gastric Emptying Scintigraphy (GES)
• Additional relevant MeSH terms: Gastroparesis

Study Results

Participant Flow

Recruitment Details	Recruitment period- January 2014 March 2017; 11 academic and community centers within the US
Pre-assignment Detail	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 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 Gastroparesis will undergo the SmartPill monitoring system test
Overall Participants	167
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	154 92.2%
>=65 years	13 7.8%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	45
Sex: Female, Male (Count of Participants)
Female	131 78.4%
Male	36 21.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	167 100%
suspected gastroparesis (Count of Participants)
Count of Participants [Participants]	167 100%

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 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 Gastroparesis will undergo the SmartPill monitoring system test
Measure Participants	152
Number (95% Confidence Interval) [percentage of agreement]	76

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SmartPill Monitoring System
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0052
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	percentage of agreement
	Estimated Value	76
	Confidence Interval	(2-Sided) 95%; 69 to 83
	Parameter Dispersion	Type: Value:
	Estimation Comments

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>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 Gastroparesis will undergo the SmartPill monitoring system test
Measure Participants	143
Number (95% Confidence Interval) [percentage of agreement]	92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SmartPill Monitoring System
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	precentage of agreement
	Estimated Value	92
	Confidence Interval	(2-Sided) 95%; 87 to 96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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)
Arm/Group Title	SmartPill Monitoring System
Arm/Group Description	patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
All Cause Mortality
	SmartPill Monitoring System
	Affected / at Risk (%)	# Events
Total	2/167 (1.2%)
Serious Adverse Events
	SmartPill Monitoring System
	Affected / at Risk (%)	# Events
Total	10/167 (6%)
Blood and lymphatic system disorders
uncontrolled high blood pressure	1/167 (0.6%)	1
Gastrointestinal disorders
Nausea and Vomiting	4/167 (2.4%)	5
exacerbation of pre-existing condition secondary to gastroparesis	1/167 (0.6%)	1
Abdominal Pain	1/167 (0.6%)	1
capsule retention	1/167 (0.6%)	1
General disorders
dehydration	1/167 (0.6%)	1
Death	2/167 (1.2%)	2
Musculoskeletal and connective tissue disorders
Right Hip Replacement	1/167 (0.6%)	1
Renal and urinary disorders
kidney translant	1/167 (0.6%)	1
Reproductive system and breast disorders
laproscopic-assisted vaginal historectomy and right salpingo-oophorectomy	1/167 (0.6%)	1
Other (Not Including Serious) Adverse Events
	SmartPill Monitoring System
	Affected / at Risk (%)	# Events
Total	18/167 (10.8%)
Gastrointestinal disorders
Abdominal Pain	5/167 (3%)	5
Diarrhea	1/167 (0.6%)	1
Nausea	1/167 (0.6%)	1
Vomiting	2/167 (1.2%)	2
Dumping syndrome	1/167 (0.6%)	1
extreme pain and bloating	1/167 (0.6%)	1
General disorders
Headache	1/167 (0.6%)	1
Musculoskeletal and connective tissue disorders
Right Hip Replacement	1/167 (0.6%)	1
Nervous system disorders
Brain Aneurysm	1/167 (0.6%)	1
facial droop, ER visit; diagnosed with Bell's palsy	1/167 (0.6%)	1
Reproductive system and breast disorders
kidney translant	3/167 (1.8%)	4
labioplasty with bilateral simple partial vulvectomy	1/167 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Upper Respitory Infection	2/167 (1.2%)	2

Limitations/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.