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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02233933
Other study ID # RadP
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 28, 2014
Last updated September 8, 2014
Start date September 2014
Est. completion date December 2015

Study information

Verified date September 2014
Source British Columbia Cancer Agency
Contact Alan A Weiss, MD
Phone 7789979332
Email aweiss@bccancer.bc.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- bleeding from radiation proctitis

Exclusion Criteria:

- pregnancy bleeding diathesis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Hemospray
hemospray is used after argon coagulation to stop bleeding

Locations

Country Name City State
Canada British Columbia Cancer Clinic Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary number of treatments required to achieve cessation of rectal bleeding 12 months No
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