Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pentax Medical
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Serious, device-related adverse events
Study Overview
Brief Summary
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
Detailed Description
Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least one unstained lesion (USL) in the esophagus upon high resolution endoscopy with Lugol's staining
- •Flat (type 0-IIb) appearance of the USL
- •Total area of USLs is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus
- •Proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
- •Older than 18 years of age at time of consent
- •Operable per institution's standards
- •Provides written informed consent on the Ethics Committee-approved informed consent form
- •Willing and able to comply with study requirements for follow-up
Exclusion Criteria
- •Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone
- •Other USLs containing MGIN, HGIN, or ESSC outside the designated treatment area
- •Any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus
- •Any previous esophageal surgery (except anti-reflux surgery)
- •Any cancer (squamous cell or non-squamous cell) within the previous five (5) years
- •Active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination
- •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
- •Pregnant or planning to become pregnant during the study follow-up period
- •Life expectancy ≤2 years
Arms & Interventions
CryoBalloon Focal Ablation System
CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia
Intervention: CryoBalloon Focal Ablation System (Device)
Outcomes
Primary Outcomes
Serious, device-related adverse events
Time Frame: Day 30
Incidence of serious, device-related adverse events
Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA
Time Frame: 3 months
Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA at three (3) months following endoscopic cryoablation. This will be evaluated by visual endoscopic exam and two (2) biopsies negative for squamous epithelial dysplasia confirmed by histopathological analysis
Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA)
Time Frame: Day 0
The percentage of subjects with successful, complete ablation of the USLs within the TA as determined by the endoscopist at the time of the treatment endoscopy(s)
Secondary Outcomes
- Adverse Events(12 Months)
- Complete eradication after one treatment(12 months)
- Procedure time(Day 0)
- Device performance(Day 0)
- Absence of USLs containing MGIN, HGIN or cancer(12 months)