Clinical trial · Interventional
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
A Prospective, Multi-center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)
NCT00526786CI-TRIAL-00014028ICEterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Reasons
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| High Grade Dysplasia | — | UNRESOLVED | — |
| Low Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoSpray Ablation System (510(k) NO: K070893) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.
- timeFrame
- 2 years post treatment
Secondary outcomes (1)
- measure
- 1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.
- timeFrame
- 2 years post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky performance status of 50-100% * Life expectancy greater than 5 years * Hematopoietic, Hepatic and Renal lab clearance * Previous endoscopy with histological confirmation of LGD or HGD within BE * For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery. * For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS). Exclusion Criteria: * Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years). * Esophageal stricture preventing passage of endoscope or catheter. * Active esophagitis * EMR performed less than 8 weeks prior to CSA treatment. * EMR performed on greater than 90% circumference of any area of the esophagus. * Any previous esophageal surgery, except fundoplication without complications. * Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. * Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints. * Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol. * Medically unfit or other contraindication to tolerate upper endoscopy. * Inability to tolerate therapy with a proton pump inhibitor (PPI). * Refusal or inability to give consent. * Other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free). * Concurrent chemotherapy. * Prior radiation therapy which involved the esophagus. * Prior adenocarcinoma involving the esophagus or stomach. * Prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.
References
Publications (6)
- BACKGROUNDChampion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6. PMID 8076761
- BACKGROUNDEisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31. PMID 8995932
- BACKGROUNDEll C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3. PMID 10734018
- BACKGROUNDJohnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4. PMID 10385730
- BACKGROUNDJohnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8. PMID 14629105
- BACKGROUNDJohnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008. PMID 16301023