NCT00526786TerminatedPhase 4
A Prospective, Multi-center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- CSA Medical, Inc.
- Enrollment
- 78
- Locations
- 16
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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).
Detailed Description
The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Time Frame: 2 years post treatment
Secondary Outcomes
- 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.(2 years post treatment)
Investigators
Study Sites (16)
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