Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
TOPAZ
Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy Versus Computed Tomographic Colonography in a Screening Population
2 other identifiers
interventional
320
1 country
13
Brief Summary
The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2018
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 1, 2019
August 1, 2019
1.9 years
April 25, 2016
August 1, 2019
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy
Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm. Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results
5-6 weeks from randomized procedure
Secondary Outcomes (4)
Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm
5-6 weeks from randomized procedure
Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm
5-6 weeks from randomized procedure
Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
5-6 weeks from randomized procedure
Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
5-6 weeks from randomized procedure
Study Arms (2)
COLON Capsule endoscopy
EXPERIMENTALSubjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the CCE procedure day. With the exception of Gastrografin, all colon preparation products will be standard colon cleansing products approved by the FDA. Between 45 and 75 minutes after the final Polyethylene Glycol (PEG) ingestion, the subject will swallow the PillCam COLON Capsule with a cup of water. If necessary, capsule position will be monitored to ensure adequate booster administration. Subjects will keep a timed diary of key preparation steps and bowel activity, including capsule excretion. Subjects will be allowed to leave the unit 10 hours after capsule ingestion if the capsule is not yet excreted. Subjects leaving before excretion will be instructed to disconnect the recorder at excretion or 12 hours after capsule ingestion (whichever comes first).
Computed Tomographic Colonography
ACTIVE COMPARATORSubjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the Computed Tomographic Colonography (CTC) procedure day. The CTC procedure and study interpretation will be conducted in accordance with the ACR-SAR-SCBT-MR Practice Parameter for the Performance of CT Colonography in Adults. Colon insufflation will be performed with the subject in the lateral decubitus or supine position.With the subject in the supine position, a CT scout image will be taken to confirm adequate colon distention. If adequate bowel distention is not achieved, additional air will be insufflated into the colon. After scanning the subject in the supine position, the subject will be placed in the prone position, and additional CO2 will be administered. Subsequently, CT will be performed with the subject in the prone position. If a prone position is not possible for the subject, a left lateral decubitus position is preferred for optimal gas and fluid redistribution.
Interventions
Eligibility Criteria
You may qualify if:
- Subject is between 50 and 75 years of age (for African Americans only, subject is between 45-75 years of age).
- Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
You may not qualify if:
- Subject with history of colorectal cancer or adenoma (including those identified by computed tomography \[CT\], optical colonoscopy \[OC\[, sigmoidoscopy, etc.).
- Subject with history of negative colonoscopy within 10 years, as these subjects would be defined as not requiring screening in this timeframe. For subjects with alternative screening methods, refer to applicable guidelines.
- Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
- Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
- Subject with current dysphagia or any swallowing disorder.
- Subject with current serious medical conditions that would increase the risk associated with CCE, CTC, or colonoscopy that are so severe that screening would have no benefit.
- Subject with a cardiac pacemaker or other implanted electromedical device.
- Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range.
- Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
- Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
- Subject has an estimated life expectancy of less than 6 months.
- Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
- Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (13)
University of South Alabama
Mobile, Alabama, 36688, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Loyola University Medical Center
Chicago, Illinois, 60153, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology and Hepatology
Indianapolis, Indiana, 46237, United States
Baystate Hospital
Springfield, Massachusetts, 01199, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Clinical Research Professionals
St Louis, Missouri, 63141, United States
NYU
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Virginia Gastroenterology institute
Suffolk, Virginia, 23434, United States
Related Publications (1)
Cash BD, Fleisher MR, Fern S, Rajan E, Haithcock R, Kastenberg DM, Pound D, Papageorgiou NP, Fernandez-Urien I, Schmelkin IJ, Rex DK. Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study). Gut. 2021 Nov;70(11):2115-2122. doi: 10.1136/gutjnl-2020-322578. Epub 2020 Dec 18.
PMID: 33443017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Liron Bar Yaakov, Senior Manager Clinical Affairs
- Organization
- Medtronic GIH (Given Imaging LTD)
Study Officials
- PRINCIPAL INVESTIGATOR
Brooks Cash, MD
University of South Alabama
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
April 28, 2016
Study Start
September 1, 2016
Primary Completion
August 7, 2018
Study Completion
August 7, 2018
Last Updated
October 1, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share