Trial Outcomes & Findings for Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population. (NCT NCT02754661)

NCT ID: NCT02754661

Last Updated: 2019-10-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 320 participants
• Primary outcome timeframe: 5-6 weeks from randomized procedure
• Results posted on: 2019-10-01

Participant Flow

Participant milestones

Measure	COLON Capsule Endoscopy Subjects who had Colon capsule followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Overall Study STARTED	160	160
Overall Study COMPLETED	145	141
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	COLON Capsule Endoscopy n=145 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=141 Participants Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.	Total n=286 Participants Total of all reporting groups
Age, Customized	55.3 year n=5 Participants	56.0 year n=7 Participants	55.7 year n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	73 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	68 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants	133 Participants n=7 Participants	271 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	115 Participants n=7 Participants	224 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	145 participants n=5 Participants	141 participants n=7 Participants	286 participants n=5 Participants
BMI (Body Mass Index)	32.2 kg/m^2 n=5 Participants	30.2 kg/m^2 n=7 Participants	31.2 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 5-6 weeks from randomized procedure

Population: 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

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

Outcome measures

Measure	COLON CAPSULE ENDOSCOPY n=133 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=128 Participants Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy	34 Participants	11 Participants

SECONDARY outcome

Timeframe: 5-6 weeks from randomized procedure

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

Outcome measures

Measure	COLON CAPSULE ENDOSCOPY n=53 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=41 Participants Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm	34 Participants	11 Participants

SECONDARY outcome

Timeframe: 5-6 weeks from randomized procedure

Population: 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

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

Outcome measures

Measure	COLON CAPSULE ENDOSCOPY n=80 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=87 Participants Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm	77 Participants	86 Participants

SECONDARY outcome

Timeframe: 5-6 weeks from randomized procedure

Population: 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) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a "per subject" basis

Outcome measures

Measure	COLON CAPSULE ENDOSCOPY n=37 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=12 Participants Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm	34 Participants	11 Participants

SECONDARY outcome

Timeframe: 5-6 weeks from randomized procedure

Population: 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

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.

Outcome measures

Measure	COLON CAPSULE ENDOSCOPY n=96 Participants Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=116 Participants Subjects who had computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm	77 Participants	86 Participants

Adverse Events

COLON Capsule Endoscopy

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Computed Tomographic Colonography

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	COLON Capsule Endoscopy n=145 participants at risk Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=141 participants at risk Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Gastrointestinal disorders Haematochezia	0.69% 1/145 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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	0.00% 0/141 • Adverse event data was collected over a 5-6 week period 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
Gastrointestinal disorders Rectal Haemorrage	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Gastrointestinal disorders Post procedural haemorrahage	0.69% 1/145 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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	0.00% 0/141 • Adverse event data was collected over a 5-6 week period 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

Other adverse events

Measure	COLON Capsule Endoscopy n=145 participants at risk Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks.	Computed Tomographic Colonography n=141 participants at risk Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks.
Eye disorders Chalazion	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Gastrointestinal disorders Abdominal pain	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Gastrointestinal disorders Anorectal discomfort	0.69% 1/145 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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	0.00% 0/141 • Adverse event data was collected over a 5-6 week period 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
Gastrointestinal disorders Haemmorrhoids	1.4% 2/145 • Number of events 2 • Adverse event data was collected over a 5-6 week period 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	0.00% 0/141 • Adverse event data was collected over a 5-6 week period 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
Infections and infestations Hordeolum	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Infections and infestations Sinusitis	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Injury, poisoning and procedural complications Procedural pain	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Investigations Blood pressure increased	0.69% 1/145 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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	0.00% 0/141 • Adverse event data was collected over a 5-6 week period 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
Nervous system disorders Presyncope	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	1.4% 2/141 • Number of events 2 • Adverse event data was collected over a 5-6 week period 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
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/145 • Adverse event data was collected over a 5-6 week period 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	0.71% 1/141 • Number of events 1 • Adverse event data was collected over a 5-6 week period 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

Additional Information

Liron Bar Yaakov, Senior Manager Clinical Affairs

Medtronic GIH (Given Imaging LTD)

Phone: 972-526060466

Email: liron.baryaakov@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place