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Recruiting NCT07089615

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

No phase Interventional Colonic Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capsule swallow.
Who it may be relevant to
Registry conditions: Colonic Polyps. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

Overview

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. It will use colonoscopy results as a reference. The participant will: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later

Interventions

  • Device Capsule swallow
    Participant will swallow the investigational device

Primary outcome measures

  • Positive Percentage Agreement [Time frame: From capsule swallow to Colonoscopy - up to 6 weeks]
  • Negative Percentage Agreement [Time frame: From Capsule swallow to colonoscopy - Up to 6 weeks]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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 participation
  • 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 screening.
  • 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 validity of the study results
  • Are currently enrolled in an interventional 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 11 centers
  • SB Gastro Clinical Research — Chula Vista
  • Gastro Care Institute — Lancaster
  • Knowledge Research Center — Orange
  • Advanced Research Institute — St. Petersburg
  • Digestive Health Services — Downers Grove
  • Gastroenterology and Internal Medicine Specialists — Lake Barrington
  • Northshore Center for Gastroenterology — Libertyville
  • Suburban Gastroenterology — Naperville
  • … and 3 more centers

Identifiers

NCT: NCT07089615 · CLN-CVI-5794 2nd Generation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗