100
Participants
Start Date
March 31, 2007
Primary Completion Date
March 31, 2010
Study Completion Date
March 31, 2012
Endoscopic spray cryotherapy
A special orogastric venting tube is passed alongside the endoscope and the cryocatheter then used to perform cryotherapy. Liquid nitrogen is sprayed through the catheter to achieve a uniform white frost in a hemicircumferential sector for 10 seconds. A thaw time of 45-60seconds is observed. This freeze-thaw cycle is repeated x 3 for a total of 40sec cryotherapy per segment. This therapy is repeated every 6 weeks until visible re-epithelialization is seen or a maximum of 6 sessions. Once a squamous lining is seen, biopsies are taken throughout the original area to assess for buried Barretts. If none is seen, followup with 4 quadrant q2cm biopsies are taken at 3,6,9,12, 18, 24, 36, 48 months.
Endoscopic spray cryotherapy
After passing a special orogastric venting tube, the cryocatheter is used to spray liquid nitrogen onto the tumor to achieve a white frost (frozen state) for 20 seconds. A 45-60 sec thaw is allowed and then retreatment x 2 for a total of 60 seconds therapy per session. Repeat treatments are permitted every 2 weeks for a maximum of 8 treatments.
RECRUITING
Walter Reed Army Medical Center, Washington D.C.
Collaborators (1)
CSA Medical, Inc.
INDUSTRY
Walter Reed Army Medical Center
FED