Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321958
Status:
TERMINATED
Last Update Posted:
2022-02-08
First Post:
2006-05-03
Brief Title:
Study of Cryotherapy Treatment of Barretts Esophagus and Early Esophageal Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cryotherapy Ablation of Barretts Esophagus and Early Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor determined that adequate data had been acquired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope cryotherapy to treat Barretts esophagus with high-grade dysplasia and early esophageal cancer It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return
Detailed Description:
Barretts esophagus BE with high grade dysplasia HGD is a precursor of esophageal adenocarcinoma Eliminating this condition may control the current rapid rise of adenocarcinoma Ablative techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost patient discomfort andor significant complications A novel device which sprays liquid nitrogen through an upper endoscope cryotherapy has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans Successful reversal of BE LGD HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment
This study is undertaken to demonstrate the efficacy and safety in the ablation of Barretts esophagus with high-grade neoplasia and severe esophageal squamous dysplasia and to confirm preliminary results in humans
This study is undertaken to demonstrate the efficacy and safety in the ablation of Barretts esophagus with high-grade neoplasia and severe esophageal squamous dysplasia and to confirm preliminary results in humans
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 |
|---|---|---|---|
| CCT Number 3511 | OTHER_GRANT | UMB | None |