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

Overview

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

Full Title of Study: “Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: argon plasma coagulation
    • argon plasma coagulation of radiation proctitis
  • Experimental: argon plasma coagulator and hemospray
    • treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray

Clinical Trial Outcome Measures

Primary Measures

  • cessation of rectal bleeding
    • Time Frame: 12 months
    • 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 Measures

  • number of treatments required to achieve cessation of rectal bleeding
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • bleeding from radiation proctitis Exclusion Criteria:

  • pregnancy bleeding diathesis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • British Columbia Cancer Agency
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alan Weiss, Principal Investgator – British Columbia Cancer Agency
  • Overall Official(s)
    • Alan A Weiss, MD, Principal Investigator, BCCA
  • Overall Contact(s)
    • Alan A Weiss, MD, 7789979332, aweiss@bccancer.bc.ca

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