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Videocapsule Endoscopy for Gastrointestinal Bleeding

N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing whether VCE is better than colonoscopy for diagnosing UGIB.

Who is the study for?
This trial is for adults over 18 who are stable after a new episode of upper gastrointestinal bleeding, evidenced by dark stools or a significant drop in hemoglobin. They must have had an initial negative gastroscopy and be able to consent. It's not for those with prior abdominal radiation, Crohn's disease, small bowel surgery or strictures, language barriers affecting consent, or pregnant women.Check my eligibility
What is being tested?
The study tests if doing an early videocapsule endoscopy right after a negative gastroscopy can improve outcomes for patients with suspected upper GI bleeding compared to the standard method which usually involves a colonoscopy first. Outcomes include diagnostic accuracy, number of procedures needed, hospital stay length, mortality rates and costs.See study design
What are the potential side effects?
Videocapsule endoscopy is generally safe but potential side effects may include discomfort during swallowing the capsule, risk of capsule retention especially in people with narrowing in their bowels (not eligible for this trial), and minor risks associated with sedation if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood pressure is stable and within normal ranges.
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I am able to understand and agree to the study's procedures and risks.
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My first stomach exam showed no signs of bleeding.
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I recently started bleeding from my gut and my blood levels have dropped significantly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic yield
Diagnostic yield of colonoscopy after initial negative gastroscopy
Secondary outcome measures
Adverse events in both groups
Length of stay in hospital
Recurrence of bleeding
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early small bowel investigationExperimental Treatment1 Intervention
Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy
Group II: ColonoscopyActive Control1 Intervention
Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Videocapsule endoscopy
2009
N/A
~70

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,888 Total Patients Enrolled

Media Library

Videocapsule Endoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108844 — N/A

Frequently Asked Questions

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

Who meets the eligibility criteria to join this clinical experiment?

"Patients between the ages of 18 and 90 who have been officially diagnosed with hematochezia are eligible to apply for this clinical trial. 70 persons will be accepted into the experiment in total."

Answered by AI

Does the age criterion for this clinical research include those aged 70 and over?

"Participants of this medical research project must be at least 18 years old and no older than 90 years old."

Answered by AI

Is the recruitment period for this clinical research still open?

"Indeed, according to clinicaltrials.gov, this trial is presently in the process of enrolling patients. Initially made available on September 1st 2021 and most recently amended on October 31st 2022, it seeks 70 individuals at one medical centre."

Answered by AI

How many applicants are being taken into consideration for participation in this research study?

"Affirmative. According to clinicaltrials.gov, this medical study is currently in the recruitment phase and has been since September 1st 2021. The most recent update was on October 31st 2022 and 70 patients are still needed from one trial site."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding
Sergio Zepeda-Gomez 2021. "Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05108844.
~10 spots leftby Sep 2024
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