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

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

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

Study Overview

• Status: Completed
• Conditions: Esophageal Squamous Cell Dysplasia
• Intervention / Treatment: Device: CryoBalloon Focal Ablation System

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CryoBalloon Focal Ablation System; CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia

Device: CryoBalloon Focal Ablation System; 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; Other Names: C2 CryoBalloon Focal Ablation System; Coldplay CryoBalloon Focal Ablation System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pentax Medical

Publications and helpful links

General Publications

• Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): January 27, 2018
• Study Completion (Actual): January 27, 2018

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: CP-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No