Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure

NCT00885235 | Completed

• 1 other identifier: MA-101
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.

Conditions

Bowel Diseases

Keywords

Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• Colon cleansing level score for PCCE

  Within 7 days

• Grading of visual interference from bubbles in the colon for PCCE

  Within 7 days

• Number of colon capsules excreted over time

  Within 7 Days

• Capsule transit time from ingestion to entrance into the cecum & through the colon

  Within 7 Days

• Number, type and severity of adverse events

  WithIn 7 days

Secondary Outcomes (3)

• Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 10mm as compared to colonoscopy

  within 7 days

• Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 6mm as compared to colonoscopy

  within 7 days

• The diagnostic yield of PCCE in detecting a variety of colonic lesions

  within 7 days

Study Arms (1)

A

Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases. The study population will consist of subjects who fulfill at least one of the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
• Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
• Subject ≥ 18 years of age with one of the following:
• Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
• Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy

You may not qualify if:

• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• Subject has a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
• Subject with gastrointestinal motility disorders
• Subject has known delayed gastric emptying
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (4)

University of Indiana Hospital

Indianapolis, Indiana, 46202, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Digestive Care Inc.

Beavercreek, Ohio, 45440, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Douglas Rex, Dr

  University of Indiana Hospital

  PRINCIPAL INVESTIGATOR

• Douglas Morgan, Dr

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 31, 2019

Record last verified: 2009-08

Locations

US (4)