NCT02099435

Brief Summary

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2016

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

March 26, 2014

Last Update Submit

January 19, 2017

Conditions

Colonic DiverticulaAngiodysplasiaColonic Polyp

Keywords

GastriointestinalLower gastriointestinalDigestiveHemostasisRecurrent bleedingHemospray

Outcome Measures

Primary Outcomes (1)

  • Percentage of device related adverse events

    30 days

Secondary Outcomes (3)

  • Percentage of recurrent bleeding that occurs outside the blood vessel

    30 days

  • Percentage of hemostasis of lower GI bleeds originating from multiple sources

    30 days

  • All cause mortality

    30 days

Study Arms (1)

Hemospray to treat lower GI bleeds

Device: Hemospray

Interventions

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.

Hemospray to treat lower GI bleeds

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

clinical sites

You may qualify if:

  • Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis

You may not qualify if:

  • 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
  • Actual or suspected lower GI perforation or fistula
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, Canada

Location

Montreal General Hospital - McGill University

Montreal, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30612959DERIVED

MeSH Terms

Conditions

Diverticulum, ColonAngiodysplasiaColonic PolypsHemorrhage

Condition Hierarchy (Ancestors)

DiverticulumDiverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesIntestinal PolypsPolypsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 28, 2014

Study Start

January 1, 2015

Primary Completion

November 6, 2016

Study Completion

November 6, 2016

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

CA(4)