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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02150941
• Other study ID #: 105394
• Status: Terminated
• Phase: N/A
• First received: May 22, 2014
• Last updated: November 14, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• BioVac Direct Suction Device
The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.
• Standard Endoscopy Suction
Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure related adverse events	Adverse events related to the EGD will be noted, including intraprocedural hypotension, oxygen desaturation, aspiration, and perforation.	Measured once 48 hours after endoscopy	Yes
Primary	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	No
Secondary	Application of any endoscopic therapy	Treated as a dichotomous outcome (yes, no). Endoscopic therapy include injection, electrocautery, hemostatic clip, variceal banding, or Hemospray	Once at the time of endoscopy	No
Secondary	Rebleeding	Rebleeding is defined to have occurred for any of the following: vomiting of fresh blood, shock (systolic blood pressure < 90 mm Hg or heart rate > 110 beats per minute) with melena after stabilization, or a drop in hemoglobin of > 20 g/L within 24 hours after a transfusion to a level > 70 g/L	Measured once 7 days after endoscopy	No
Secondary	Transfusion requirement	Total number of units of blood transfused 7 days after endoscopy	Measured once 7 days after endoscopy	No
Secondary	Length of hospital stay		Measured once 30 days after endoscopy	No
Secondary	Need for interventional radiology or surgery		Measured once 30 days after endoscopy	No
Secondary	30 day mortality		Measured once 30 days after endoscopy	No
Secondary	Need for repeat EGD within 72 hours		Measured once 7 days after endoscopy	No
Secondary	Procedure duration		Once at the time of endoscopy video review	No