Ignite Creation Date:
2024-05-05 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00650988
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2008-03-30
Brief Title:
Cryotherapy for Barretts Esophagus and Early Esophageal Cancers
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study of Cryotherapy for Barretts Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter cryotherapy via an upper endoscopy EGD to ablate Barretts esophagus with changes of high-grade dysplasia HGD or intramucosal cancer IMCA and patients with esophageal cancer limited to the esophageal wall in whom there are no standard treatment options available
Detailed Description:
The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold
Patients will prepare for esophagogastroduodenoscopy EGD in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure The EGD will be performed using a therapeutic Olympus endoscope The cryocatheter is passed into the therapeutic channel of the endoscope Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds Following circumferential treatment the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds Patients will be contacted the following day to assess for any immediate complications
Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury until complete ablation of the Barretts mucosa has been achieved Follow up period of five years to monitor healing and progression
Patients will prepare for esophagogastroduodenoscopy EGD in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure The EGD will be performed using a therapeutic Olympus endoscope The cryocatheter is passed into the therapeutic channel of the endoscope Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds Following circumferential treatment the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds Patients will be contacted the following day to assess for any immediate complications
Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury until complete ablation of the Barretts mucosa has been achieved Follow up period of five years to monitor healing and progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Cleveland Clinic IRB 8270 | OTHER | Cleveland Clinic IRB | None |