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Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01306864
Acronym
HALT
Enrollment
67
Registered
2011-03-02
Start date
2011-12-31
Completion date
2017-05-29
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Peptic Ulcers

Keywords

Endoscopic Hemostasis, Peptic Ulcer, Recurrent Bleeding, Injection Therapy, Thermal Probe

Brief 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.

Interventions

DEVICEHemospray Kit

Hemostasis of Arterial GI Bleeding

Sponsors

Cook Group Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Bleeding peptic ulcer

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Proportion of patients with further bleed72 Hours

Secondary

MeasureTime frame
Proportion of patients with initial hemostasisAt the conclusion of the index procedure

Countries

Canada, Hong Kong, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026