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

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.

Study Overview

• Status: Completed
• Conditions: Ulcer; Celiac Disease; Crohn Disease; Inflammatory Bowel Disease; Intestinal Disease
• Intervention / Treatment: Device: PillCam SB2 capsule; Device: CapsoCam SV-1

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Pacific Gastroenterology Associates GI Research Institute
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Shabana F. Pasha, MD
  • Florida
    • Miami, Florida, United States, 33173
      • Gastro Health
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Ziad Younes, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal vs Abnormal, Overall Impression	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.	Study Completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2	Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.	Study Completion
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2	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.	Study Completion
Preference Between CapsoCam SV-1 and PillCam SB2	Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects	Study Completion

Collaborators and Investigators

• Sponsor: Capso Vision, Inc.
• Investigators: Principal Investigator: Shabana F Pasha, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: inflammatory bowel disease; celiac disease; ulcer; polyp; crohn disease; intestinal disease; angioectasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Gastroenteritis; Malabsorption Syndromes; Inflammatory Bowel Diseases; Celiac Disease; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: Capso Vision SV-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO