Gastrointestinal HemorrhageNCT02150941
Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding
A study testing BioVac Direct Suction Device and Standard Endoscopy Suction in people with Gastrointestinal Hemorrhage, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- BioVac Direct Suction Device and Standard Endoscopy Suction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- BioVac Direct Suction Device, Standard Endoscopy Suction
- Keywords
- Upper gastrointestinal tract, Endoscopy, Endoscopic Hemostasis
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioVac Direct Suction DeviceDevice
The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.
Standard Endoscopy SuctionDevice
Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).
| Study group | Role | What they receive |
|---|---|---|
| BioVac Direct Suction Device | Experimental | Experimental arm Receives: Device: BioVac Direct Suction Device |
| Standard Endoscopy Suction | Active comparator | Control arm Receives: Device: Standard Endoscopy Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Once at the time of endoscopy
Secondary outcomes (8)
Application of any endoscopic therapy
Treated as a dichotomous outcome (yes, no). Endoscopic therapy include injection, electrocautery, hemostatic clip, variceal banding, or Hemospray
Measured: Once at the time of endoscopy
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: Measured once 7 days after endoscopy
Transfusion requirement
Total number of units of blood transfused 7 days after endoscopy
Measured: Measured once 7 days after endoscopy
Length of hospital stay
Measured: Measured once 30 days after endoscopy
Need for interventional radiology or surgery
Measured: Measured once 30 days after endoscopy
30 day mortality
Measured: Measured once 30 days after endoscopy
Need for repeat EGD within 72 hours
Measured: Measured once 7 days after endoscopy
Procedure duration
Measured: Once at the time of endoscopy video review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Enrollment too slow to complete the trial in a reasonable amount of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sai Lai Sey, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael SL Sey, MD, Principal investigator, London Health Sciences Centre-Victoria Campus, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150941
- Sponsor's protocol ID
- 105394
- Status last verified
- Nov 2016
- First submitted
- 22 May 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the BioVac Direct Suction Device Increase Identification of the Bleeding Source in Upper Gastrointestinal Bleeding: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02150941
- Acronym / sponsor ID
- 105394
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Upper gastrointestinal tract, Endoscopy, Endoscopic Hemostasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too slow to complete the trial in a reasonable amount of time.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioVac Direct Suction Device | Experimental | Device: BioVac Direct Suction DeviceExperimental arm |
| Standard Endoscopy Suction | Active comparator | Device: Standard Endoscopy SuctionControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioVac Direct Suction DeviceThe BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope. | Device | BioVac Direct Suction Device |
| Standard Endoscopy SuctionStandard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III). | Device | Standard Endoscopy Suction |
Primary outcome
Identification of cause of bleeding on upper endoscopy
Time frame: Once at the time of endoscopy
The cause of bleeding will be classified by location (esophagus, stomach, duodenum) and etiology (inflammation, ulcer, mass, varices, angioectasia, Dieulafoy, other).
8 secondary outcomes
Application of any endoscopic therapy
Time frame: Once at the time of endoscopy
Rebleeding
Time frame: Measured once 7 days after endoscopy
Transfusion requirement
Time frame: Measured once 7 days after endoscopy
Length of hospital stay
Time frame: Measured once 30 days after endoscopy
Need for interventional radiology or surgery
Time frame: Measured once 30 days after endoscopy
30 day mortality
Time frame: Measured once 30 days after endoscopy
Need for repeat EGD within 72 hours
Time frame: Measured once 7 days after endoscopy
Procedure duration
Time frame: Once at the time of endoscopy video review
Results and safety
The study was stopped early (reason given: Enrollment too slow to complete the trial in a reasonable amount of time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael SL Sey, MD principal investigator
London Health Sciences Centre-Victoria Campus, Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioVac Direct Suction Device and Standard Endoscopy Suction in people with Gastrointestinal Hemorrhage, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment too slow to complete the trial in a reasonable amount of time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cause of bleeding on upper endoscopy (time frame: Once at the time of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.