Back to resultsTrial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
Primary Purpose
Rectal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hemospray
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Bleeding focused on measuring radiation proctitis, bleeding, therapy
Eligibility Criteria
Inclusion Criteria:
- bleeding from radiation proctitis
Exclusion Criteria:
- pregnancy bleeding diathesis
Sites / Locations
- British Columbia Cancer Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
argon plasma coagulation
argon plasma coagulator and hemospray
Arm Description
argon plasma coagulation of radiation proctitis
treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
number of treatments required to achieve cessation of rectal bleeding
Full Information
NCT ID
NCT02233933
First Posted
August 28, 2014
Last Updated
September 8, 2014
Sponsor
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT02233933
Brief Title
Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
Official Title
Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Bleeding
Keywords
radiation proctitis, bleeding, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
argon plasma coagulation
Arm Type
Active Comparator
Arm Description
argon plasma coagulation of radiation proctitis
Arm Title
argon plasma coagulator and hemospray
Arm Type
Experimental
Arm Description
treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
Intervention Type
Other
Intervention Name(s)
Hemospray
Intervention Description
hemospray is used after argon coagulation to stop bleeding
Primary Outcome Measure Information:
Title
cessation of rectal bleeding
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
number of treatments required to achieve cessation of rectal bleeding
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bleeding from radiation proctitis
Exclusion Criteria:
pregnancy bleeding diathesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan A Weiss, MD
Phone
7789979332
Email
aweiss@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan A Weiss, MD
Organizational Affiliation
BCCA
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan A Weiss, MD
Phone
778 9979332
Email
aweiss@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Alan A Weiss, MD
12. IPD Sharing Statement
Learn more about this trial
Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
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