NCT02820077

Brief Summary

This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 6, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

3.5 years

First QC Date

June 7, 2016

Last Update Submit

August 27, 2020

Conditions

Gastrointestinal HemorrhageGastrointestinal Neoplasms

Keywords

Endoscopy, Gastrointestinal

Outcome Measures

Primary Outcomes (2)

  • rebleeding

    until 30 days after endoscopy

  • mortality

    until 30 days after endoscopy

Secondary Outcomes (2)

  • Successful initial hemostasis

    From the moment of the procedure until 24 hours after it

  • Hospital length of stay

    from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months

Study Arms (2)

Hemospray

EXPERIMENTAL

Patients treated with hemostatic powder

Device: Hemospray (Endoscopic treatment with hemostatic powder)

Clinical support

NO INTERVENTION

Patients treated with optimal clinical management, as it is been advised by the latest guidelines

Interventions

Hemospray (Endoscopic treatment with hemostatic powder)DEVICE

Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Hemospray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any kind of malignancy
  • Gastrointestinal bleeding in the last 48 hours
  • Referred to emergency endoscopy

You may not qualify if:

  • under 18 years old
  • bleeding from non malignant lesions
  • previous endoscopic treatment with another method done in the last 48h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal HemorrhageGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 30, 2016

Study Start

August 6, 2016

Primary Completion

January 24, 2020

Study Completion

August 27, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share