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Video Capsule Endoscopy

Video Capsule Endoscopy for Vomiting Blood

N/A

Waitlist Available

Led By David R Cave, MD, PhD

Research Sponsored by Christopher Marshall

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to one year

Awards & highlights

Study Summary

This trial will compare the use of a video capsule endoscopy to the standard of care workup for patients with symptoms of gastrointestinal bleeding.

Eligible Conditions

Gastrointestinal Bleeding
Vomiting Blood
Black Stool

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Detection of Bleeding

Time to Detection of Bleeding

Secondary outcome measures

Admission Rate

Endoscopic Procedures

Hospital Length of Stay

+2 more

Other outcome measures

Blood Product Transfusions

Complication Rates

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early Capsule GroupExperimental Treatment1 Intervention

The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.

Group II: Standard of Care Work-upActive Control1 Intervention

In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Video Capsule Endoscopy

2020

N/A

~40

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Find a Location

Who is running the clinical trial?

Olympus Corporation of the AmericasIndustry Sponsor

20 Previous Clinical Trials

2,180 Total Patients Enrolled

Christopher MarshallLead Sponsor

David CaveLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the essential purpose of this trial?

"The primary aim of this study, which lasts for a maximum duration of 720 hours or the time taken to detect bleeding (whichever is sooner), is to measure the rate of detection of bleeding. Secondary objectives include evaluating the number of invasive procedures, re-admission rates and therapeutic procedures administered throughout the trial period."

Answered by AI

To what extent is this research endeavor being utilized by the general public?

"Affirmative, clinicaltrials.gov data indicates that recruitment for this research project is still open and actively being pursued. Initially posted on February 4th 2020 and last edited March 12th 2022, 160 patients are needed from a single site."

Answered by AI

Has recruitment for this experiment been closed or is it ongoing?

"As indicated on clinicaltrials.gov, this research is currently recruiting participants; the trial was initially advertised on February 4th 2020 and recently updated on March 12th 2022."

Answered by AI

Recent research and studies

Gastrointestinal EndoscopyJournal

Timing of Video Capsule Endoscopy Relative to Overt Obscure GI Bleeding: Implications from a Retrospective Study

Singh, Anupam, Christopher Marshall, Biswashree Chaudhuri, Chidimma Okoli, Anne Foley, Sharina D. Person, Kanishka Bhattacharya, and David R. Cave. 2013. “Timing of Video Capsule Endoscopy Relative to Overt Obscure GI Bleeding: Implications from a Retrospective Study”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2012.11.041.

Gastrointestinal EndoscopyJournal

A Randomized Controlled Trial Comparing Efficacy of Early Video Capsule Endoscopy with Standard of Care in the Approach to Nonhematemesis GI Bleeding (with Videos)

Marya, Neil B., Salmaan Jawaid, Anne Foley, Samuel Han, Krunal Patel, Louise Maranda, Daniel Kaufman, et al.. 2019. “A Randomized Controlled Trial Comparing Efficacy of Early Video Capsule Endoscopy with Standard of Care in the Approach to Nonhematemesis GI Bleeding (with Videos)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2018.06.016.

clinicaltrials.govStudy

Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding

Christopher Marshall 2020. "Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03955055.