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

July 29, 2019 updated by: Medtronic - MITG
The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule excretion rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, an ingestible device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.

The PillCam™ SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 500,000 people worldwide and is well accepted by patients and physicians as well as the processional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.

This is a pilot study that is designed to evaluate the level of cleanliness and visualization of colon achieved by colon capsule endoscopy when using Night procedure regimens for preparation of the colon.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliche Universitätskliniken Bergmannsheil
      • Bochum, Germany, 44892
        • Knappschaftskrankenhaus Medizinische Universitaetsklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR
  • Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study - no more than 25% of total cases

Exclusion criteria

  • Subject has dysphagia or any swallowing disorder
  • Subject has severe Congestive heart failure (NYHA II or IV)
  • Subject has 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 judgement of the investigator
  • Subject has a cardiac pacemaker or other implanted electromedical 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.
Device: PillCam™ (Capsule Endoscopy)
Medical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colon cleansing level score
Time Frame: within 7 days
within 7 days
Transit time in the different GI regions until excretion
Time Frame: within 7 days
within 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient subjective assessment questionnaires
Time Frame: within 7 days
within 7 days
Number of complete capsule procedure
Time Frame: within 7 days
within 7 days
Accuracy parameters of PCCE, compared to colonoscopy
Time Frame: within 7 days
within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Wolff Schmiegel, Prof. Dr., Knappschaftskrankenhaus Medizinische Universitaetsklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 2, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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