Colonic Transit Time Validation Study (CTT)

SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation

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.

Study Overview

• Status: Unknown
• Conditions: Constipation

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.

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

Study Locations

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      • Withdrawn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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with constipation referred to a tertiary motility center

Description

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.

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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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Constipated; Adult subjects with functional constipation as define by Rome II criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colonic Transit Time	4 days and 7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine regional gut (gastric, small bowel, colonic) transit times	continuous time measure until caspule elimination

Collaborators and Investigators

• Sponsor: The SmartPill Corporation
• Investigators: Study Chair: John R Semler, PHD, The SmartPill Corporation

Publications and helpful links

General Publications

• Camilleri M, Thorne NK, Ringel Y, Hasler WL, Kuo B, Esfandyari T, Gupta A, Scott SM, McCallum RW, Parkman HP, Soffer E, Wilding GE, Semler JR, Rao SS. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010 Aug;22(8):874-82, e233. doi: 10.1111/j.1365-2982.2010.01517.x. Epub 2010 May 11.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: gastric emptying; capsule; constipation; whole gut transit; colonic transit; small bowel transit
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 120508