Clinical trial NCT04246632: CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
Official title: Prospective, Open Label, Pilot Study of the CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lead sponsor: Capso Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Assessments
timeFrame: Day 1
Secondary outcomes:
measure: Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)
timeFrame: Day 1-3
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Silicon Valley Research Institute, Inc.
state: California
city: Saratoga
country: United States
facility: CapsoVision Research Clinic
state: California
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
Study officials:
References: