Colonic DiverticulaNCT02099435
Study of Hemospray for Lower Gastrointestinal Hemorrhage
An observational study of Colonic Diverticula and Angiodysplasia, run by Cook Group Incorporated at 4 sites in Canada.
Trial summary
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colonic Diverticula, Angiodysplasia, Colonic Polyp
- What is being tested?
- Hemospray
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 4 sitesCanada
- Study dates
- Jan 2015to 6 Nov 2016
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinical sites
Who may be able to join
- Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis
Who cannot join
- Less than 19 years old
- Unwilling or unable to sign and date the informed consent
- Pregnant, lactating or planning to become pregnant within 30 days of the procedure
- Contraindicated to undergo colonoscopy
- Medical/Endoscopic Exclusion Criteria
- Actual or suspected lower GI perforation or fistula
Show all 10Show fewer
- Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- Actual or suspected ischemic colitis or infectious colitis
- Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
- Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Royal Alexandra Hospital
Edmonton, Alberta
University of Alberta Hospital
Edmonton, Alberta
Hotel Dieu Hospital
Kingston, Ontario
Montreal General Hospital - McGill University
Montreal, Quebec
About this study
Official title: A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
- Conditions
- Colonic Diverticula, Angiodysplasia, Colonic Polyp
- Being tested
- Hemospray
- Keywords
- Gastriointestinal, Lower gastriointestinal, Digestive, Hemostasis, Recurrent bleeding, Hemospray
- Medical subject headings
- Diverticulum, Colon, Angiodysplasia, Colonic Polyps, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemosprayDevice
The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Hemospray to treat lower GI bleeds | Not described Receives: Device: Hemospray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of device related adverse events
Measured: 30 days
Secondary outcomes (3)
Percentage of recurrent bleeding that occurs outside the blood vessel
Measured: 30 days
Percentage of hemostasis of lower GI bleeds originating from multiple sources
Measured: 30 days
All cause mortality
Mortality within 30 days of index procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2015
- Primary completion6 Nov 2016
- Study completion6 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic DiverticulaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099435
- Sponsor's protocol ID
- 12-007
- Status last verified
- Jan 2017
- First submitted
- 26 Mar 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hookey L, Barkun A, Sultanian R, Bailey R. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019 Apr;89(4):865-871. doi: 10.1016/j.gie.2018.10.029. Epub 2018 Oct 26.
PubMed 30612959
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
- ClinicalTrials.gov ID
- NCT02099435
- Acronym / sponsor ID
- 12-007
- Conditions
- Colonic Diverticula, Angiodysplasia, Colonic Polyp
- Keywords
- Gastriointestinal, Lower gastriointestinal, Digestive, Hemostasis, Recurrent bleeding, Hemospray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 6 Nov 2016 (actual)
- Study completion
- 6 Nov 2016 (actual)
- First posted
- 28 Mar 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.
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemospray to treat lower GI bleeds | – | Device: Hemospray |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinical sites
Key inclusion criteria (1 listed)
- Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis
Key exclusion criteria (10 listed)
- Less than 19 years old
- Unwilling or unable to sign and date the informed consent
- Pregnant, lactating or planning to become pregnant within 30 days of the procedure
- Contraindicated to undergo colonoscopy
- Medical/Endoscopic Exclusion Criteria
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 |
|---|---|---|
| HemosprayThe Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa. | Device | Hemospray to treat lower GI bleeds |
Primary outcome
Percentage of device related adverse events
Time frame: 30 days
3 secondary outcomes
Percentage of recurrent bleeding that occurs outside the blood vessel
Time frame: 30 days
Percentage of hemostasis of lower GI bleeds originating from multiple sources
Time frame: 30 days
All cause mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Derived from this study: PubMed 30612959Hookey L, Barkun A, Sultanian R, Bailey R. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019 Apr;89(4):865-871. doi: 10.1016/j.gie.2018.10.029. Epub 2018 Oct 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diverticula and Angiodysplasia, run by Cook Group Incorporated at 4 sites 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of device related adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099435, which also lists 1 linked publication.
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 20 Jan 2017.