NCT02233933

Brief Summary

Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

August 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

August 28, 2014

Last Update Submit

September 8, 2014

Conditions

Rectal Bleeding

Keywords

radiation proctitisbleedingtherapy

Outcome Measures

Primary Outcomes (1)

  • cessation of rectal bleeding

    treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray

    12 months

Secondary Outcomes (1)

  • number of treatments required to achieve cessation of rectal bleeding

    12 months

Study Arms (2)

argon plasma coagulation

ACTIVE COMPARATOR

argon plasma coagulation of radiation proctitis

Other: Hemospray

argon plasma coagulator and hemospray

EXPERIMENTAL

treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray

Other: Hemospray

Interventions

HemosprayOTHER

hemospray is used after argon coagulation to stop bleeding

argon plasma coagulationargon plasma coagulator and hemospray

Eligibility Criteria

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

You may qualify if:

  • bleeding from radiation proctitis

You may not qualify if:

  • pregnancy bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Clinic

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageHemorrhage

Interventions

hemospray

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alan A Weiss, MD

    BCCA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan A Weiss, MD

CONTACT

7789979332aweiss@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investgator

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 9, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CA(1)