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Subjects 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).

Subjects 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.

COLON Capsule endoscopy

Computed Tomographic Colonography

Brooks Cash, MD

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.

This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus CTC in the identification of colonic polyps in a screening population.

Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened by the gastroenterology site for study participation at a baseline visit which will also include a blood test for renal function (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC procedure to assess subject well-being and capture any Adverse Events (AEs), regardless of relationship to the CCE, CTC, or Optical colonoscopy (OC) procedures.

All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All study analyses will be based on central reader results for both CCE and CTC. Two sets of central readers will be utilized, one set for reading of the CCE RAPID® videos and one set for reading the CTC studies. Both groups of readers will be experts in the reading process for their respective procedures. Readers will provide a report of their findings to the sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The first OC procedure will be performed with the clinician blinded to the CCE or CTC results. Immediately following this blinded procedure, the clinician will review the CCE or CTC results report provided by the sponsor from the central readers, and a second unblinded OC procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.

Colonoscopy must not be performed by the same person who conducts the local CCE reading, or anyone who has reviewed CCE/CTC results for that subject.

Bowel preparation regimens for all three procedure types will be standardized across sites.

Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.

Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy Versus Computed Tomographic Colonography in a Screening Population

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

Sensitivity (the percentage of patients with disease who test positive) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis

Specificity (the percentage of patients without disease who test negative) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis

Predictive value of a positive test (PPV) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a "per subject" basis

Predictive value of a negative test (NPV) is the percentage of patients with negative tests who do not have disease, assessed in relation to the confirmatory OC results on a "per subject" basis.

Medtronic - MITG

Adverse events have been collected at the start of the CCE/CTC bowel preparation up until colonoscopy Follow-up call. The following AEs and serious adverse events (SAEs) were collected:

* All adverse events related to the CCE, CTC and or OC procedures
* All retained capsules greater than 14 days
* All perforations
* All device deficiencies that may lead to a SAE
* All adverse events that meet serious adverse event definition
* All deaths

Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.

COLON Capsule Endoscopy

Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

BMI (Body Mass Index)

Baseline Analysis population is based on the Full Analysis set defined as all randomized subjects who underwent colonoscopy and CTC or CCE procedures.

Liron Bar Yaakov, Senior Manager Clinical Affairs

COLON CAPSULE ENDOSCOPY

Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.

Per protocol Analysis set (PPAS) is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure

Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy

Per protocol Analysis (PPAS) set is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure

Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm

Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm

Per protocol Analysis set is comprised of all randomized subjects without major protocol deviations (violations that may have a significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure

Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm

Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm

Subjects who had Colon capsule followed by optical colonoscopy within 5-6 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.	NCT02754661	Colorectal Canc...	COLON Capsule e... Computed Tomogr...	50 Years - 75 Years	Medtronic - MITG
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.	NCT02754661	Colorectal Canc...	COLON Capsule e... Computed Tomogr...	50 Years - 75 Years	Medtronic - MITG

Spots Global Cancer Trial Database for polyps; capsule endoscopy; ct colonography; colonoscopy; average risk patients for colorectal cancer screening