Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

Study Overview
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Brief Summary
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To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.

Detailed Description
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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.

Official Title
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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

Conditions
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Esophageal Squamous Cell Dysplasia

Intervention / Treatment
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* Device: CryoBalloon Focal Ablation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CryoBalloon Focal Ablation System<br>CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia | Device: CryoBalloon Focal Ablation System<br>* Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia<br>* Other names: Coldplay CryoBalloon Focal Ablation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious, device-related adverse events | Incidence of serious, device-related adverse events | Day 30 | 
| Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA) | 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) | Day 0 | 
| Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of USLs containing MGIN, HGIN or cancer | Efficacy defined as the absence of USLs containing MGIN, HGIN or cancer within the original TA after the last endoscopic ablation. | 12 months | 
| Complete eradication after one treatment | Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System | 12 months | 
| Device performance | Device performance, assessed by Device malfunction | Day 0 | 
| Procedure time | Procedure time, defined as the time from the introduction of the endoscope to its removal | Day 0 | 
| Adverse Events | Incidence of all treatment-related and serious, non-device related adverse events | 12 Months |