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Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding

NCT ID: NCT02150941

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-08-31

Brief Summary

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Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.

A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.

Detailed Description

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STUDY DESIGN:

This is a randomized double blind clinical trial of the BioVac suction device versus standard endoscopy suction for UGIB. The study will be performed at London Health Sciences Center Victoria Campus and University Campus with an anticipated recruitment period of 2.5 years.

STUDY POPULATION:

All patients over the age of 18 admitted to hospital with a diagnosis of UGIB will be considered for recruitment. Patients already admitted to hospital with another diagnosis who develop UGIB will also be included.

INTERVENTION:

Patients will undergo EGD for UGIB as per standard clinical practice. If the bleeding source is not found within the first 5 minutes (timer starts once EGD passes upper esophageal sphincter) due to blood clots, the patient may benefit from additional suctioning. The patient will be randomized in blocks of 2-6 stratified by site to either the BioVac device or endoscopy suction. Those randomized to the BioVac device will use it to irrigate and suction as much blood as possible until the bleeding source is found or until the endoscopist feels that additional time would not help. Those randomized to endoscopy suction will do the same without the BioVac device. Due to the suctioning power of the study device, a placebo is not possible. Our original intention was to record the endoscopy video to blindly assess the outcome. Unfortunately, this ended up not being possible for technical reasons.

Conditions

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Gastrointestinal Hemorrhage

Keywords

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Upper gastrointestinal tract Endoscopy Endoscopic Hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BioVac Direct Suction Device

Experimental arm

Group Type EXPERIMENTAL

BioVac Direct Suction Device

Intervention Type DEVICE

The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.

Standard Endoscopy Suction

Control arm

Group Type ACTIVE_COMPARATOR

Standard Endoscopy Suction

Intervention Type DEVICE

Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).

Interventions

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BioVac Direct Suction Device

The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.

Intervention Type DEVICE

Standard Endoscopy Suction

Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena
2. Patients with hematochezia and hypotension (systolic blood pressure \< 90 mm Hg) or tachycardia (heart rate \> 110 beats per minute)

Exclusion Criteria

1. Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning.
2. Age \< 18.
3. No endoscopy was performed.
4. Endoscopy previously performed for current episode of UGIB.
5. Patients unable to consent and who do not have a substitute decision maker.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Michael Sai Lai Sey, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael SL Sey, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre-Victoria Campus, Western University

Locations

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London Health Sciences Center

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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105394

Identifier Type: -

Identifier Source: org_study_id