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

Pentax Medical

Status: Completed

Conditions: Esophageal Squamous Cell Dysplasia

Treatments: Device: CryoBalloon Focal Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02605759

CP-0013

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

CryoBalloon Focal Ablation System

Experimental group

Description:

CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia

Treatment:

Device: CryoBalloon Focal Ablation System