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Compares treatment options for Colonic Polyps
Official title Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
ClinicalTrials.gov ID: NCT07089615
What this study is testing
- What it's testing
- Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied. The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 45-75 years of age
- Committed to undergo a colonoscopy.
- Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to...
You likely can't join if
- Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- Has contraindication for capsule endoscopy or colonoscopy
- Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
- Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- History of incomplete colonoscopy
- Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C\>6.4 within the past 3 months and/or with history of constipation or gastroparesis).
See the full eligibility criteria
- 45-75 years of age
- Committed to undergo a colonoscopy.
- Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor
- Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- Has contraindication for capsule endoscopy or colonoscopy
- Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
- Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- History of incomplete colonoscopy
- Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C\>6.4 within the past 3 months and/or with history of constipation or gastroparesis).
- Impaired cardiac function assessed as greater than NYHA Class II
- History of small- or large-bowel obstructive condition
- Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
- 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 subject at greater risk for capsule endoscope retention
- Known allergy to ingredients used in bowel preparation and boosters
- Daily and/or regular narcotic use
- Decompensated cirrhosis
- Prior abdominal radiation therapy
- Diagnosis of anorexia or bulimia
- History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study...
- Known or suspected megacolon
- Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
- Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
- Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at...
- Unable to follow or tolerate fasting, bowel preparation, and other study procedures
- 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 or would affect the...
- Are currently enrolled in an treatment clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
- Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Lancaster, California, United States
- Orange, California, United States
- St. Petersburg, Florida, United States
- Downers Grove, Illinois, United States
- Lake Barrington, Illinois, United States
- Libertyville, Illinois, United States
- Naperville, Illinois, United States
- Oak Lawn, Illinois, United States
- Rochester, New York, United States
- Mentor, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Lancaster, California, United States; Orange, California, United States; St. Petersburg, Florida, United States; Downers Grove, Illinois, United States; Lake Barrington, Illinois, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.