Cyrotherapy vs. APC in GAVE

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

April 30, 2010

Conditions
Watermelon Stomach
Interventions
PROCEDURE

cryotherapy

"The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.~A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy."

PROCEDURE

Argon Plasma Coagulation

As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy

Trial Locations (1)

55905

Mayo CLinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER