Evaluation of the PillCam™ Colon Capsule -2 System

NCT00884624 | Completed

• 1 other identifier: MA-200
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.

Conditions

Bowel Diseases

Keywords

Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy

  Within 7 Days

• Assessment of colon cleansing level at different colon segments

  Within 7 days

• Distribution of capsule excretion time

  Within 7 Days

• Percent of excreted capsules up to 10 hours post capsule ingestion.

  Within 7 Days

• Number, type and severity of adverse events

  WithIn 7 days

Secondary Outcomes (8)

• Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy

  within 7 days

• Capsule transit time within stomach, small bowel and colon

  within 7 days

• Number of polyps and sizes at different colon segments detected by capsule

  within 7 days

• Number of polyps and sizes at different colon segments detected by conventional colonoscopy

  within 7 days

• RAPID video reading time

  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 - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject is between the ages of 18-57 years.
• Subject is able and agrees to sign the Informed Consent Form
• Subject was referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
• Positive findings in the colon on a GI radiographic study
• Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since last conventional colonoscopy
• Positive findings in the colon
• Personal history of polyps that were removed at least 5 years ago (5 years and more)

You may not qualify if:

• Subject has dysphagia
• Subject has congestive heart failure
• Subject has renal insufficiency
• Subject has Nephrotic syndrome
• Subject has Cirrhosis
• Subject is known or is suspected to suffer from intestinal obstruction.
• Subject is taking NSAID medication
• Subject suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers
• Chronic use of laxatives
• Subject has a cardiac pacemakers or other implanted electro medical devices.
• Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• 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 any condition, which precludes compliance with study and/or device instructions.
• Age \< 18 years or under parent guardian

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (5)

Hillel Yaffe Hospital

Hadera, 38101, Israel

Location

Rambam - Medical center

Haifa, 31096, Israel

Location

Bikkur Holim Hospital

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, 95347, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Rami Eliakim, Prof.

  Rambam Health Care Campus

  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: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 31, 2019

Record last verified: 2010-03

Locations

IL (5)