Colonoscopy
Conditions
Brief summary
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
Interventions
DEVICECapsoCam Colon Capsule Endoscopy
CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
Sponsors
Capso Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
PI is masked to Capsule results and capsule reader is masked to colonoscopy results.
Intervention model description
Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 50 and 75 years old 2. Subject meets at least one of the following criteria for increased risk for polyps: 1. Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test 2. Older than 55 years of age, without prior history of colonoscopy 3. Has had a positive colonoscopy ≥ 5 years prior to screening visit 4. And/or having at least two of the following risk factors: * Current smoker * BMI of ≥30 * Family history (blood relative) of colorectal cancer * Sedentary lifestyle * Low fiber/ high fat diet 3. No contraindication for capsule endoscopy or colonoscopy 4. Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion 5. Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor
Exclusion criteria
1. History of negative colonoscopy within the last 10 years 2. History of incomplete colonoscopy 3. Impaired cardiac function assessed as greater than NYHA Class II 4. History of small- or large-bowel obstructive condition 5. Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis 6. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention 7. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 8. Known allergy to ingredients used in bowel preparation and boosters 9. Daily and/or regular use of narcotics 10. Known or suspected AIDS 11. Uncompensated cirrhosis 12. Prior abdominal radiation therapy 13. Diagnosis of anorexia or bulimia 14. History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion 15. Known or suspected megacolon 16. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule 17. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 18. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening. 19. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study 20. Are currently enrolled in, or participated in within the last 30 days, another clinical study 21. Chronic constipation as defined by \<3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening 22. History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessments | Day 1 | Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) | Day 1-3 | All adverse events including SAEs/UADEs will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be reported. A serious adverse event is one that meets the definition outlined in Section 8 of this protocol. |
Countries
United States
Outcome results
None listed