Trial Outcomes & Findings for Evaluation of PillCam™ Colon 2 in Visualization of the Colon (NCT NCT01087528)

Results Overview

The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

within 7 days

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison..
Overall Study STARTED	51
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison..
Overall Study Withdrawal by Subject	1
Overall Study Incomplete CE procedure	6

Baseline Characteristics

Evaluation of PillCam™ Colon 2 in Visualization of the Colon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=51 Participants Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison..
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	60.22 years STANDARD_DEVIATION 6.87 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: within 7 days

Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.

The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

Outcome measures

Outcome measures
Measure	PillCam COLON n=44 Participants Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.	Standard Colonoscopy All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
Accuracy of Detection in Patients With Colonic Polyps - Sensitivity Patients with Polyp>= 6 mm	89 percentage of sensiivity Interval 61.0 to 98.0	—
Accuracy of Detection in Patients With Colonic Polyps - Sensitivity Patients with Polyp, >= 10 mm	100 percentage of sensiivity Interval 46.0 to 100.0	—

PRIMARY outcome

Timeframe: within 7 days

Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.

The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

Outcome measures

Outcome measures
Measure	PillCam COLON n=44 Participants Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.	Standard Colonoscopy All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
Accuracy of Detection in Patients With Colonic Polyps - Specificity Patients with Polyp>= 6 mm	43 percentage of specificity Interval 36.0 to 45.0	—
Accuracy of Detection in Patients With Colonic Polyps - Specificity Patients with Polyp, >= 10 mm	66 percentage of specificity Interval 62.0 to 66.0	—

SECONDARY outcome

Timeframe: within 7 days

Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.

The diagnostic yield (%) of PCCE-2 and colonoscopy in visualizing a variety of colonic lesion excluding polyps (e.g. inflammation, diverticulosis and bleeding lesions) is provided.

Outcome measures

Outcome measures
Measure	PillCam COLON n=44 Participants Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.	Standard Colonoscopy n=44 Participants All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions %Patients Yield Diverticulosis	83 percentage of yield	61 percentage of yield
Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions %Patients Yield Inflamatory	4.5 percentage of yield	9 percentage of yield
Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions %Patients Yield Angiodysplasia	4.5 percentage of yield	0 percentage of yield

SECONDARY outcome

Timeframe: within 7 days

Population: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.

Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.)

Outcome measures

Outcome measures
Measure	PillCam COLON n=44 Participants Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.	Standard Colonoscopy n=44 Participants All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Overall	61 percentage of participants Interval 46.0 to 75.0	86 percentage of participants Interval 73.0 to 94.0
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Rectum	43 percentage of participants Interval 31.0 to 67.0	92 percentage of participants Interval 81.0 to 98.0
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Decending Colon	83 percentage of participants Interval 67.0 to 93.0	86 percentage of participants Interval 73.0 to 94.0
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Transverse Colon	59 percentage of participants Interval 42.0 to 74.0	82 percentage of participants Interval 69.0 to 91.0
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Ascending Colon	61 percentage of participants Interval 46.0 to 75.0	88 percentage of participants Interval 75.0 to 95.0
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) Cecum	63 percentage of participants Interval 47.0 to 76.0	88 percentage of participants Interval 75.0 to 95.0

SECONDARY outcome

Timeframe: within 7 days

Population: All subject who ingested the capsule were included in this analysis

Capsule excretion time is defined as the duration of ingestion to capsule excretion time. The distribution of excretion times were categorized as follows: * capsule excreted within 4 hours * capsule excreted within 6 hours * capsule excreted within 8 hours * capsule excreted 8 hours and above

Outcome measures

Outcome measures
Measure	PillCam COLON n=50 Participants Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.	Standard Colonoscopy All subjects received ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy. Results compare capsule vs. colonoscopy.
Capsule Excretion Time excreted 8hr+	21 Participants	—
Capsule Excretion Time excreated <4hr	8 Participants	—
Capsule Excretion Time excreated >4h and <6hr	13 Participants	—
Capsule Excretion Time excreated >6hr ans <8hr	8 Participants	—

Adverse Events

Colon Capsule Endoscopy, Then Standard Colonoscopy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=51 participants at risk Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison..
Gastrointestinal disorders bruising to abdomen	2.0% 1/51 • Number of events 1
Eye disorders Left eye pain	2.0% 1/51 • Number of events 1
Gastrointestinal disorders Abdominal Pain	2.0% 1/51 • Number of events 1

Additional Information

Hilla Debby/Director of clinical affairs

Givenimaging

Phone: 972490977740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place