Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis

NCT ID: NCT02233933

Last Updated: 2014-09-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination

Conditions

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Rectal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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argon plasma coagulation

argon plasma coagulation of radiation proctitis

Group Type ACTIVE_COMPARATOR

Hemospray

Intervention Type OTHER

hemospray is used after argon coagulation to stop bleeding

argon plasma coagulator and hemospray

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

Group Type EXPERIMENTAL

Hemospray

Intervention Type OTHER

hemospray is used after argon coagulation to stop bleeding

Interventions

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Hemospray

hemospray is used after argon coagulation to stop bleeding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* bleeding from radiation proctitis

Exclusion Criteria

* pregnancy bleeding diathesis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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Alan Weiss

Principal Investgator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan A Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

BCCA

Locations

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British Columbia Cancer Clinic

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Alan A Weiss, MD

Role: CONTACT

7789979332

Facility Contacts

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Alan A Weiss, MD

Role: primary

778 9979332

Other Identifiers

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RadP

Identifier Type: -

Identifier Source: org_study_id

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