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

NCT01787825 | Completed Results

• 1 other identifier: Capso Vision SV-1
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 7

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.

Conditions

Intestinal Disease; Inflammatory Bowel Disease; Crohn Disease; Ulcer; Celiac Disease

Keywords

intestinal disease; inflammatory bowel disease; crohn disease; ulcer; celiac disease; angioectasia; polyp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2

  Study Completion

• Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2

  Study Completion

• Preference Between CapsoCam SV-1 and PillCam SB2

  Study Completion

Study Arms (2)

PillCam SB2 then CapsoCam SV-1

OTHER

PillCam SB2 capsule then CapsoCam SV-1 capsule

Device: PillCam SB2 capsule; Device: CapsoCam SV-1

CapsoCam SV-1 then PillCam SB2

OTHER

CapsoCam SV-1 capsule then PillCam SB2 capsule

Device: PillCam SB2 capsule; Device: CapsoCam SV-1

Interventions

PillCam SB2 capsule DEVICE

Capsule Endoscopy system

Also known as: capsule endoscopy system

CapsoCam SV-1 then PillCam SB2; PillCam SB2 then CapsoCam SV-1

CapsoCam SV-1 DEVICE

Capsule endoscopy

Also known as: Capsule endoscopy

CapsoCam SV-1 then PillCam SB2; PillCam SB2 then CapsoCam SV-1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 to 85 years of age (inclusive).
• Willing and able to provide written informed consent.
• 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.
• 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.

You may not qualify if:

• Subjects who had a prior negative capsule endoscopy (within 1 year of study).
• Known or suspected obstruction or stricture unless patency capsule confirms patency.
• Known or suspected gastrointestinal perforation.
• Known or suspected small bowel diverticuli.
• Known swallowing disorder or the inability or unwillingness to swallow pills.
• Radiation or chemotherapy induced enteritis.
• History of Zenker's or known duodenal or jejunal diverticula.
• Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms
• 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).
• Subjects with DNR/DNI "do not resuscitate/do not intubate" status.
• Known or suspected gastrointestinal dysmotility.
• Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant.
• History of skin reaction to adhesives.
• 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.
• Subjects who are scheduled for an MRI within 30 days of the last study visit.

Sponsors & Collaborators

• Capso Vision, Inc.: lead

Study Sites (7)

Shabana F. Pasha, MD

Scottsdale, Arizona, 85259, United States

Location

Gastro Health

Miami, Florida, 33173, United States

Location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ziad Younes, MD

Germantown, Tennessee, 38138, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Pacific Gastroenterology Associates GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

MeSH Terms

Conditions

Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease; Polyps

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: CapsoVision, Inc.

andra.thomas@capsovision.com

408-624-1488

Study Officials

• Shabana F Pasha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: February 11, 2013
• Study Start: May 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)