Cyrotherapy vs. APC in GAVE - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

September 14, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00587405 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Endoscopic response will constitute the secondary outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Cyrotherapy vs. APC in GAVE

Official Title ^ICMJE

Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach

Brief Summary

To see if either method of treatment for Watermelon Stomach shows better results

Detailed Description

Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. Current endoscopic treatment options, including argon plasma coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat WS by virtue of its mechanism of injury and mode of application.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Watermelon Stomach

Intervention ^ICMJE

Procedure: cryotherapy
Procedure: Argon Plasma Coagulation

Study Arms / Comparison Groups

Active Comparator: Cryotherapy
Active Comparator: Argon Plasma Coagulation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Confirmed WS at endoscopy that is associated with significant anemia (Hb < 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months
Able to give informed consent
Age > 18 years

Exclusion Criteria:

Endoscopic or histological findings inconsistent with WS
Known coagulopathy (INR > 2), severe thrombocytopenia (platelet count < 50,000), or bleeding diathesis
Endoscopic treatment of WS within the past month
Unable or unwilling to give informed consent.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Louis M Wongkeesong, MD	507-255-8692	wong.louis@mayo.edu
Contact: Kelly T Dunagan	507-255-8692	dunagan.kelly@mayo.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00587405

Responsible Party

Louis Michel WongKeeSong, Mayo Clinic

Study ID Numbers ^ICMJE

2261-05

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Louis M Wongkeesong, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP