Trial record 1 of 1 for:    NCT00857363
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Colonic Transit Time Validation Study (CTT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by The SmartPill Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The SmartPill Corporation
ClinicalTrials.gov Identifier:
NCT00857363
First received: March 4, 2009
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

The protocol described herein is designed to provide clinical evidence of the substantial equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals, Easton, MD) radio-opaque markers (ROM). The trial will enroll symptomatic subjects who meet Rome III criteria (1) for chronic functional constipation.


Condition
Constipation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation

Resource links provided by NLM:


Further study details as provided by The SmartPill Corporation:

Primary Outcome Measures:
  • Colonic Transit Time [ Time Frame: 4 days and 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine regional gut (gastric, small bowel, colonic) transit times [ Time Frame: continuous time measure until caspule elimination ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Constipated
Adult subjects with functional constipation as define by Rome II criteria

Detailed Description:

The primary aim of this study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are derived from the 95th percentile of the healthy subjects in the study. Demonstration of agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated by comparing the percentage of subjects identified with slow transit versus normal transit with SmartPill to the percentage of subjects identified with slow versus normal transit with ROM in the study population. The colonic transit time results will serve as the primary measure for slow versus normal transit for SmartPill. For ROM test we will employ the Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill results to. Additionally, we will characterize gastric emptying and small bowel transit time of the SmartPill in this population. The SmartPill test will be administered simultaneously with ROM. A modified Metcalf procedure will be employed for characterization of slow transit by ROM.

The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18 years of age to 80 years of age.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with constipation referred to a tertiary motility center

Criteria

Inclusion Criteria:

  1. Males and females between ages of 18-80 years of age with symptoms of chronic functional constipation for at least one year.
  2. Self reported bowel movement frequency of < 2 bowel movements/week for at least 3 of the last 6 months.
  3. Presenting at least one of the following symptoms as defined by Rome III criteria

    • Feeling of incomplete evacuation with > 25% of bowel movements
    • Digital maneuvers with > 25% of bowel movements
    • Hard stools with > 25% of bowel movements
    • Feeling of blockage with > 25% of bowel movements
    • Straining with > 25% of bowel movements
  4. Constipation, not abdominal pain, as the predominant symptom.
  5. Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
  6. Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
  7. No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
  8. A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.

    -

Exclusion Criteria:

  1. Participation in the previous SmartPill Whole gut transit Study titled "Assessment of Whole Gut Transit Time Using the SmartPill Capsule: A Multicenter Study" Protocol Number 122205
  2. Previous history of bezoars.
  3. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
  4. Any abdominal surgery within the past 3 months
  5. Known or history of inflammatory bowel disease
  6. History of diverticulitis, diverticular stricture, and other intestinal strictures
  7. Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
  8. Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
  9. BMI > 40 kg/m2
  10. Allergies to components of the SmartBar (Appendix IX).
  11. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion). Acceptable forms of birth control include oral contraceptives, double barrier method, and IUD cover and must be practiced from the time of enrollment until the time of release from the study.
  12. Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
  13. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
  14. Any contraindication to use of Fleets Enema.
  15. Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
  16. Severe dysphagia to food or pills

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857363

Contacts
Contact: Kelli Regan 716-882-0701 ext 120 kregan@smartpillcorp.com
Contact: Tracy Crawford 716-882-0701 ext 124 tcrawford@smartpillcorp.com

Locations
United States, Arizona
University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System Withdrawn
Tucson, Arizona, United States, 85723
United States, California
Cedars-Sinai Medical Center Completed
Los Angeles, California, United States, 90048
United States, Iowa
University of Iowa Completed
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Med Center Completed
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital Completed
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Med Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lina Nahlawi    734-936-2761    lnahlawi@med.umich.edu   
Principal Investigator: Richard Saad, MD         
Jasper Clinic, Inc. Completed
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
United States, New York
University of Buffalo VA Medical Center Completed
Buffalo, New York, United States, 14215
United States, North Carolina
University of North Carolina Medical Center Completed
Chapel Hill, North Carolina, United States, 27516
Wake Forest University Medical Center Completed
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Medical Center Completed
Philadelphia, Pennsylvania, United States, 19140
United Kingdom
Queen Mary, University of London Completed
London, United Kingdom
Sponsors and Collaborators
The SmartPill Corporation
Investigators
Study Chair: John R Semler, PHD The SmartPill Corporation
  More Information

No publications provided by The SmartPill Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jack Semler/Chief Technology Officer, The SmartPill Corporation
ClinicalTrials.gov Identifier: NCT00857363     History of Changes
Other Study ID Numbers: 120508
Study First Received: March 4, 2009
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by The SmartPill Corporation:
capsule
constipation
whole gut transit
colonic transit
gastric emptying
small bowel transit

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014