NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

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.)

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