Colonoscopy, Endoscopy
Conditions
Keywords
CE, colonoscopy, colon, Eligable for colon evaluation
Brief summary
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.
Detailed 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).
Interventions
OTHERPillCam® COLON 2 procedure using MgC boosts
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.
OTHERPillCam® COLON 2 procedure using Suprep boosts
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
OTHERPillCam® COLON 2 procedure using reduced dose of Suprep boosts
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
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Capsule excretion rate | 10 hours post capsule ingestion |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of PillCam® COLON 2 excretion times | Up to 12 hours and at least 12 hours |
Countries
United States
Outcome results
None listed