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

Rectal Bleeding Clinical Trial

Official title:

Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02233933
• Other study ID #: RadP
• 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

• Proctitis
• Rectal Bleeding

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