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Stein E, Clarke JO, Hutfless S, et al. Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 110 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 May. (Future Research Needs Papers, No. 27.)

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Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 110 [Internet].

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Appendix BList of Ongoing Studies

Title/ Identifier(s)Study DatesDescriptionSponsor or Principal
Investigator
Collaborator(s)
Source
Title:
Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Identifier(s):
NCT01469819
Start date:
November 2011

Estimated study completion date:
December 2012

Estimated primary completion date:
December 2012 (Final data collection date for primary outcome measure)
Purpose:
To measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone.

Study design:
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition(s):
Chronic Idiopathic Constipation

Intervention(s):
Drug: Lubiprostone

Estimated enrollment: 15
Texas Tech University Health Sciences Center
Takeda Pharmaceuticals North America, Inc.
ClinicalTrials​.gov

Accessed at:
clinicaltrials.gov/ct2/show/NCT01469819
Title:
SmartPill Monitoring for Assessment of GI Function in SCI

Identifier(s):
NCT00856648
Start date:
April 2009

Estimated study completion date:
December 2011

Estimated primary completion date:
April 2011 (Final data collection date for primary outcome measure)
Purpose:
To evaluate the relationship between the level of SCI and the impairment of Colonic transit time (CTT) and Total transit time (TTT) by using the SmartPill device.

Study design:
Observational Model: Case Control
Time Perspective: Prospective

Condition(s):
SCI

Intervention(s):
Device: SmartPill ingestion and monitoring

Estimated enrollment: 40
Department of Veterans AffairsClinicalTrials​.gov

Accessed at:
clinicaltrials.gov/ct2/show/NCT00856648
Title:
A New Method for Determining Gastric Acid Output Using a Wireless Capsule

Identifier(s):
NCT00702533
Start date:
June 2008

Estimated study completion date:
Ongoing (Currently recruiting participants)

Estimated primary completion date:
Ongoing (currently recruiting participants)
Purpose:
To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures.

Study design:
Observational, Time Perspective: Prospective

Condition(s):
Gastrointestinal Diseases

Intervention(s):
Wireless Capsule
SmartPill

Estimated enrollment: 80
National Institute of Diabetes and Digestive and Kidney DiseasesClinicalTrials​.gov

Accessed at:
clinicaltrials.gov/ct2/show/NCT00702533
Title:
Evaluation of Gastrointestinal Motility With SmartPill

Identifier(s):
NCT01159002
Start date:
November 2007

Estimated study completion date:
January 2009

Estimated primary completion date:
May 2008 (Final data collection date for primary outcome measure)
Purpose:
To evaluate the clinical usefulness of a capsule (SmartPill∼) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time.

Study design:
Observational Model: Cohort
Time Perspective: Prospective

Condition(s):
Gastrointestinal Motility

Intervention(s):
Device: SmartPill

Estimated enrollment: 8
University of LouisvilleClinicalTrials​.gov

Accessed at:
clinicaltrials.gov/ct2/show/NCT01159002

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