CTT: Colonic Transit Time Validation Study

Sponsor

The SmartPill Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00857363

Collaborator

(none)

210

Enrollment

Locations

Duration (Months)

16.2

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Constipated Adult subjects with functional constipation as define by Rome II criteria

Outcome Measures

Primary Outcome Measures

Colonic Transit Time [4 days and 7 days]

Secondary Outcome Measures

Determine regional gut (gastric, small bowel, colonic) transit times [continuous time measure until caspule elimination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Constipation, not abdominal pain, as the predominant symptom.
Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.

Exclusion Criteria:

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
Previous history of bezoars.
Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
Any abdominal surgery within the past 3 months
Known or history of inflammatory bowel disease
History of diverticulitis, diverticular stricture, and other intestinal strictures
Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
BMI > 40 kg/m2
Allergies to components of the SmartBar (Appendix IX).
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.
Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
Any contraindication to use of Fleets Enema.
Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
Severe dysphagia to food or pills

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System	Tucson	Arizona	United States	85723
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	University of Iowa	Iowa City	Iowa	United States	52242
4	University of Kansas Med Center	Kansas City	Kansas	United States	66160
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	University of Michigan Med Center	Ann Arbor	Michigan	United States	48109
7	Jasper Clinic, Inc.	Kalamazoo	Michigan	United States	49007
8	Mayo Clinic	Rochester	Minnesota	United States	55905
9	University of Buffalo VA Medical Center	Buffalo	New York	United States	14215
10	University of North Carolina Medical Center	Chapel Hill	North Carolina	United States	27516
11	Wake Forest University Medical Center	Winston Salem	North Carolina	United States	27157
12	Temple University Medical Center	Philadelphia	Pennsylvania	United States	19140
13	Queen Mary, University of London	London		United Kingdom