Bleeding Peptic UlcersHALTNCT01306864
Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
A study testing Hemospray Kit in people with Bleeding Peptic Ulcers, run by Cook Group Incorporated at 12 sites in 4 countries.
Trial summary
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Peptic Ulcers
- What is being tested?
- Hemospray Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Dec 2011to 29 May 2017
- 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
- Bleeding peptic ulcer
Who cannot join
- Patient is: < 18 years of age
- Patient is unable to consent
- Patient is contraindicated to undergo endoscopy
- Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
- Patient is pregnant or lactating
- Patinet has an INR > 2.5
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Canada7 sites
Royal Alexandra
Edmonton, Alberta, TSH 4B9
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Center
London, Ontario, N6A 4G5
McGill University Health Center
Montreal, Quebec, H3G 1A4
The Ottawa Hospital- Civic Campus and General Campus
Ottawa, Ontario, K1Y 4E9
Vancouver Coastal Health
Vancouver, British Columbia
Health Science Centre University of Manitoba
Winnipeg, Manitoba, R3A 1R9
United Kingdom3 sites
Belfast City Hospital
Belfast, BT9 7AB
Bradford Teaching Hospital NHS Foundation
Bradford, BD96RJ
University of Nottingham
Nottingham, NG 2UH
About this study
Official title: Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.
- Conditions
- Bleeding Peptic Ulcers
- Being tested
- Hemospray Kit
- Keywords
- Endoscopic Hemostasis, Peptic Ulcer, Recurrent Bleeding, Injection Therapy, Thermal Probe
- Medical subject headings
- Peptic Ulcer, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemospray KitDevice
Also called Endoscopic Hemostasis
Hemostasis of Arterial GI Bleeding
| Study group | Role | What they receive |
|---|---|---|
| Hemospray Treatment | Experimental | Hemospray Kit Receives: Device: Hemospray Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with further bleed
Measured: 72 Hours
Secondary outcomes (1)
Proportion of patients with initial hemostasis
Measured: At the conclusion of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startDec 2011
- Primary completion30 Apr 2017
- Study completion29 May 2017
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 Bleeding Peptic UlcersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 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
- NCT01306864
- Sponsor's protocol ID
- 10-017
- Acronym
- HALT
- Status last verified
- Feb 2018
- First submitted
- 17 Feb 2011
- Last updated
- 5 Feb 2018
- Results posted
- No
Publications
Sung JJY, Moreea S, Dhaliwal H, Moffatt DC, Ragunath K, Ponich T, Barkun AN, Kuipers EJ, Bailey R, Donnellan F, Wagner D, Sanborn K, Lau J. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022 Jul;96(1):28-35.e1. doi: 10.1016/j.gie.2022.01.020. Epub 2022 Feb 3.
PubMed 35124074
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
- ClinicalTrials.gov ID
- NCT01306864
- Acronym / sponsor ID
- HALT / 10-017
- Conditions
- Bleeding Peptic Ulcers
- Keywords
- Endoscopic Hemostasis, Peptic Ulcer, Recurrent Bleeding, Injection Therapy, Thermal Probe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 29 May 2017 (actual)
- First posted
- 2 Mar 2011 (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.
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemospray Treatment | Experimental | Device: Hemospray KitHemospray Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bleeding peptic ulcer
Key exclusion criteria (6 listed)
- Patient is: < 18 years of age
- Patient is unable to consent
- Patient is contraindicated to undergo endoscopy
- Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
- Patient is pregnant or lactating
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 |
|---|---|---|
| Hemospray KitAlso: Endoscopic HemostasisHemostasis of Arterial GI Bleeding | Device | Hemospray Treatment |
Primary outcome
Proportion of patients with further bleed
Time frame: 72 Hours
1 secondary outcome
Proportion of patients with initial hemostasis
Time frame: At the conclusion of the index procedure
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 5 Feb 2018.
- Derived from this study: PubMed 35124074Sung JJY, Moreea S, Dhaliwal H, Moffatt DC, Ragunath K, Ponich T, Barkun AN, Kuipers EJ, Bailey R, Donnellan F, Wagner D, Sanborn K, Lau J. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022 Jul;96(1):28-35.e1. doi: 10.1016/j.gie.2022.01.020. Epub 2022 Feb 3.
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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.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemospray Kit in people with Bleeding Peptic Ulcers, run by Cook Group Incorporated at 12 sites in 4 countries.
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 6 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United Kingdom, Hong Kong, Netherlands. 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?
Proportion of patients with further bleed (time frame: 72 Hours). 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 NCT01306864, 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 5 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.