Hemostasis of Active Gastrointestinal (GI) Luminal Tract... | NCT01306864

Studies
Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

NCT01306864

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Feb 5, 2018Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Bleeding Peptic Ulcers

Interventions

Hemospray Kit

Countries

Canada
Hong Kong
Netherlands
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Apr 30, 2017Actual

Completion Date

May 29, 2017Actual

First Submitted Date

Feb 17, 2011

First Submission Date that Met QC Criteria

Feb 28, 2011

First Posted Date

Mar 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2018

Last Update Posted Date

Feb 5, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemospray Treatment	Experimental	Hemospray Kit	Device: Hemospray Kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemospray Kit	Device	Hemostasis of Arterial GI Bleeding	Hemospray Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with further bleed		72 Hours

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with initial hemostasis		At the conclusion of the index procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Alexandra		Edmonton	Alberta	TSH 4B9	Canada
Vancouver Coastal Health

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35124074	Derived	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.

ID	Term
D010437	Peptic Ulcer
D006470	Hemorrhage

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D006489	Hemostatic Techniques
D013812	Therapeutics