Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease

• Sponsor: Capso Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01787825
• Collaborator: (none)
• Enrollment: 121
• Locations: 7
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 17.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Disease; Inflammatory Bowel Disease; Crohn Disease; Ulcer; Celiac Disease	Device: PillCam SB2 capsule; Device: CapsoCam SV-1	N/A

Detailed Description

This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: PillCam SB2 then CapsoCam SV-1 PillCam SB2 capsule then CapsoCam SV-1 capsule	Device: PillCam SB2 capsule; Capsule Endoscopy system; Other Names: capsule endoscopy system ; Device: CapsoCam SV-1; Capsule endoscopy; Other Names: Capsule endoscopy
Other: CapsoCam SV-1 then PillCam SB2 CapsoCam SV-1 capsule then PillCam SB2 capsule	Device: PillCam SB2 capsule; Capsule Endoscopy system; Other Names: capsule endoscopy system ; Device: CapsoCam SV-1; Capsule endoscopy; Other Names: Capsule endoscopy

Outcome Measures

Primary Outcome Measures

1. Normal vs Abnormal, Overall Impression [Study Completion]

   The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.

Secondary Outcome Measures

1. Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2 [Study Completion]

   Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.

2. Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2 [Study Completion]

   Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.

3. Preference Between CapsoCam SV-1 and PillCam SB2 [Study Completion]

   Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female between 18 to 85 years of age (inclusive).

2. Willing and able to provide written informed consent.

3. Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease [should have had patency capsule, CT or MR enterography before entry], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome.

4. If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values <31% in males or <28% in females.

Exclusion Criteria:

1. Subjects who had a prior negative capsule endoscopy (within 1 year of study).

2. Known or suspected obstruction or stricture unless patency capsule confirms patency.

3. Known or suspected gastrointestinal perforation.

4. Known or suspected small bowel diverticuli.

5. Known swallowing disorder or the inability or unwillingness to swallow pills.

6. Radiation or chemotherapy induced enteritis.

7. History of Zenker's or known duodenal or jejunal diverticula.

8. Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms

9. Subjects who are high risk for undergoing surgical interventions (i.e., to CONFIDENTIAL CapsoVision Protocol SV-1 Revision: October 17, 2011 7 remove the capsule when capsule retention occurs).

10. Subjects with DNR/DNI "do not resuscitate/do not intubate" status.

11. Known or suspected gastrointestinal dysmotility.

12. Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant.

13. History of skin reaction to adhesives.

14. Subjects who in the Investigator's opinion should not consume the 2L GoLytely and 10 mg bisacodyl study drugs, because it could pose a significant additional risk to the subject because of the subject's medical condition.

15. Subjects who are scheduled for an MRI within 30 days of the last study visit.

16. Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening.

17. Prisoners.

18. Mental and/or physical condition precluding compliance with the study and/or device instructions.

19. Participation in another clinical study within past 30 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shabana F. Pasha, MD	Scottsdale	Arizona	United States	85259
2	Gastro Health	Miami	Florida	United States	33173
3	University of Massachusetts, Worcester	Worcester	Massachusetts	United States	01655
4	Medical University of South Carolina	Charleston	South Carolina	United States	29425
5	Ziad Younes, MD	Germantown	Tennessee	United States	38138
6	UT Southwestern Medical Center	Dallas	Texas	United States	75390
7	Pacific Gastroenterology Associates GI Research Institute	Vancouver	British Columbia	Canada	V6Z 2K5

Sponsors and Collaborators

• Capso Vision, Inc.

Investigators

• Principal Investigator: Shabana F Pasha, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Capso Vision, Inc.
• ClinicalTrials.gov Identifier: NCT01787825
• Other Study ID Numbers: Capso Vision SV-1
• First Posted: Feb 11, 2013
• Last Update Posted: May 10, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Capso Vision, Inc.: intestinal disease; inflammatory bowel disease; crohn disease; ulcer; celiac disease; angioectasia; polyp
• Additional relevant MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Celiac Disease

Study Results

Participant Flow

Recruitment Details	Subjects recruited from population of patients prescribed capsule endoscopy for OGIB

Arm/Group Title	CapsoCam SV-1 Then PillCam SB2	PillCam SB2 Then CapsoCam SV-1
Arm/Group Description	Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2	Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
Period Title: Overall Study
STARTED	60	61
COMPLETED	54	60
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy The analysis population consisted of subjects that swallowed the capsules.
Overall Participants	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (15.42)
Sex: Female, Male (Count of Participants)
Female	51 42.5%
Male	69 57.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	29 24.2%
Not Hispanic or Latino	91 75.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	6 5%
Native Hawaiian or Other Pacific Islander	1 0.8%
Black or African American	5 4.2%
White	104 86.7%
More than one race	0 0%
Unknown or Not Reported	4 3.3%
Region of Enrollment (participants) [Number]
Canada	40 33.3%
United States	80 66.7%

Outcome Measures

1. Primary Outcome

Title	Normal vs Abnormal, Overall Impression
Description	The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
Time Frame	Study Completion

Outcome Measure Data

Analysis Population Description

Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.

Arm/Group Title	CapsoCam SV-1	PillCam SB2
Arm/Group Description	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
Measure Participants	114	114
Abnormal	42 35%	42 NaN
Normal	72 60%	72 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CapsoCam SV-1, PillCam SB2
	Comments	There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.
	Type of Statistical Test	Non-Inferiority
	Comments	This is McNemar design.
Statistical Test of Hypothesis	p-Value	1.0000
	Comments	The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	percentage concordance
	Estimated Value	77.19
	Confidence Interval	(2-Sided) 95%; 68.68 to 83.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Overall concordance of clinically significant abnormal images.

2. Secondary Outcome

Title	Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
Description	Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.
Time Frame	Study Completion

Outcome Measure Data

Analysis Population Description

For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.

Arm/Group Title	CapsoCam SV-1	PillCam SB2
Arm/Group Description	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
Measure Participants	112	110
Mean (Standard Deviation) [hours]	4.1 (1.85)	3.6 (1.56)

3. Secondary Outcome

Title	Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Description	Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.
Time Frame	Study Completion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CapsoCam SV-1	PillCam SB2
Arm/Group Description	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.	Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
Measure Participants	114	114
Normal	71 59.2%	70 NaN
Vascular	24 20%	21 NaN
Mass/Polyp	1 0.8%	4 NaN
Blood	1 0.8%	3 NaN
Ulcerative	15 12.5%	14 NaN
Other	2 1.7%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CapsoCam SV-1, PillCam SB2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.972
	Comments
	Method	Bowkers
	Comments
Method of Estimation	Estimation Parameter	percentage concordance
	Estimated Value	71.93
	Confidence Interval	(2-Sided) 95%; 63.07 to 79.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Preference Between CapsoCam SV-1 and PillCam SB2
Description	Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects
Time Frame	Study Completion

Outcome Measure Data

Analysis Population Description

For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.

Arm/Group Title	CapsoCam SV-1 Preference	PillCam SB2
Arm/Group Description	Subject preference for CapsoCam SV-1	Subject preference for PillCam SB2
Measure Participants	113	113
Number [participants]	89 74.2%	24 NaN

Adverse Events

Time Frame	Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
Arm/Group Title	All Study Participants
Arm/Group Description	PillCam SB Capsule and CapsoCam SV-1
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	2/120 (1.7%)
Gastrointestinal disorders
Capsule Endoscope Retention	2/120 (1.7%)	2
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	12/120 (10%)
Gastrointestinal disorders
GI Tract discomfort or pain and nausea	6/120 (5%)	6
Malaise	1/120 (0.8%)	1
Delayed Capsule Excretion	1/120 (0.8%)	1
Nervous system disorders
Migraine Headache	1/120 (0.8%)	1
Renal and urinary disorders
Right Kidney Pain	1/120 (0.8%)	1
Skin and subcutaneous tissue disorders
Skin Irritation and Itchiness	2/120 (1.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.