Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen

Medtronic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colonoscopy; Endoscopy

Treatments: Other: PillCam® COLON 2 procedure using MgC boosts; Other: PillCam® COLON 2 procedure using Suprep boosts; Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts

Study type: Interventional

Funder types: Industry

Identifiers

NCT01185002

MA-111

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subject has dysphagia or any swallowing disorder
2. Subject has congestive heart failure
3. Subject has Diabetes type I.
4. 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
5. Subject has a cardiac pacemaker or other implanted electro medical device.
6. Subject has any allergy or other known contraindication to the medications used in the study
7. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
8. 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.
9. Subject with gastrointestinal motility disorders
10. Subject has known delayed gastric emptying
11. Subject has any condition, which precludes compliance with study and/or device instructions.
12. 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.
13. Subject suffers from life threatening conditions
14. Subject currently participating in another clinical study

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

MgC boosts

Experimental group

Description:

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered MgC boosts.

Treatment:

Other: PillCam® COLON 2 procedure using MgC boosts

Suprep boosts

Experimental group

Description:

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered Suprep boosts

Treatment:

Other: PillCam® COLON 2 procedure using Suprep boosts

Suprep boosts - Reduced dose

Experimental group

Description:

Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered a reduced dose of Suprep boosts

Treatment:

Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts