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Completed

NCT Number: NCT01185002

Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alabama Digestive Disorders Center, Huntsville, Alabama, United States

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About this study

Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is between 50 - 75 years of age.
  • Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion criteria

  • Subject has dysphagia or any swallowing disorder
  • Subject has congestive heart failure
  • Subject has Diabetes type I.
  • Subject has had prior abdominal surgery 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, and incomplete colonoscopies due to obstructions 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.
  • Subject suffers from life threatening conditions
  • Subject currently participating in another clinical study

Treatment and study plan

PillCam® COLON 2 procedure using MgC boosts

Other

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.

PillCam® COLON 2 procedure using Suprep boosts

Other

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts

PillCam® COLON 2 procedure using reduced dose of Suprep boosts

Other

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts

Primary outcomes

  1. Capsule excretion rate

    Time frame: 10 hours post capsule ingestion

Secondary outcomes

  1. Distribution of PillCam® COLON 2 excretion times

    Time frame: Up to 12 hours and at least 12 hours

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2010
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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