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

NCT02150941 | Terminated DMC

• 1 other identifier: 105394
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Hemorrhage

Keywords

Upper gastrointestinal tract; Endoscopy; Endoscopic Hemostasis

Outcome Measures

Primary Outcomes (1)

• Identification of cause of bleeding on upper endoscopy

  The cause of bleeding will be classified by location (esophagus, stomach, duodenum) and etiology (inflammation, ulcer, mass, varices, angioectasia, Dieulafoy, other).

  Once at the time of endoscopy

Secondary Outcomes (8)

• Application of any endoscopic therapy

  Once at the time of endoscopy

• Rebleeding

  Measured once 7 days after endoscopy

• Transfusion requirement

  Measured once 7 days after endoscopy

• Length of hospital stay

  Measured once 30 days after endoscopy

• Need for interventional radiology or surgery

  Measured once 30 days after endoscopy

Other Outcomes (1)

• Procedure related adverse events

  Measured once 48 hours after endoscopy

Study Arms (2)

BioVac Direct Suction Device

EXPERIMENTAL

Experimental arm

Device: BioVac Direct Suction Device

Standard Endoscopy Suction

ACTIVE COMPARATOR

Control arm

Device: Standard Endoscopy Suction

Interventions

BioVac Direct Suction Device DEVICE

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

BioVac Direct Suction Device

Standard Endoscopy Suction DEVICE

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

Standard Endoscopy Suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Age \< 18.
• No endoscopy was performed.
• Endoscopy previously performed for current episode of UGIB.
• Patients unable to consent and who do not have a substitute decision maker.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael SL Sey, MD

  London Health Sciences Centre-Victoria Campus, Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 30, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

CA (1)