Endoesophageal Cryotherapy For Ablating Barrett's Esophagus and Early Stage Esophageal Cancer

PHASE4UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2012

Conditions
Barrett's Esophagus
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

20307

RECRUITING

Walter Reed Army Medical Center, Washington D.C.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CSA Medical, Inc.

INDUSTRY

lead

Walter Reed Army Medical Center

FED

NCT00628784 - Endoesophageal Cryotherapy For Ablating Barrett's Esophagus and Early Stage Esophageal Cancer | Biotech Hunter | Biotech Hunter