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

NCT00604292 | Completed

• 1 other identifier: MA-102
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the effect of a modified preparation and procedure on colon cleansing level

Conditions

Colonic Diseases

Keywords

Colonic Diseases

Outcome Measures

Primary Outcomes (1)

• Colon cleansing level score

  within 7 days

Secondary Outcomes (1)

• Accuracy parameters of PCCE, compared to colonoscopy

  within 7 days

Study Arms (1)

A

Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic 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

Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases

You may qualify if:

• Subject is between the ages of 18-75 years.
• Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study)

You may not qualify if:

• The presence of any of the following will exclude a subject from study enrollment:
• Subject has dysphagia or any swallowing disorder
• Subject has Congestive heart failure
• Subject is known to suffer from diabetes
• Subject has high degree of renal insufficiency
• 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 pacemakers or other implanted electromedical devices.
• 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 high risk for capsule retention: Crohn's disease, SB tumors, radiation enteritis, NSAID, surgical anastomosis,
• 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, who intend to be during the study period, or are of child bearing potential and do not practice medically acceptable methods of contraception
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

Klinikum Ludwigshafen gGMBH

Ludwigshafen, Bremserster 79, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, Germany

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Juergen Riemann, Prof. Dr.

  Klinikum Ludwigshafen gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: January 30, 2008
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 31, 2019

Record last verified: 2010-03

Locations

DE (3)