Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Bleeding Peptic Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemospray Treatment

Hemospray Kit

Group Type EXPERIMENTAL

Hemospray Kit

Intervention Type DEVICE

Hemostasis of Arterial GI Bleeding

Interventions

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Hemospray Kit

Hemostasis of Arterial GI Bleeding

Intervention Type DEVICE

Other Intervention Names

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Endoscopic Hemostasis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No