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

NCT ID: NCT02605759

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-01-27

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.

Conditions

Esophageal Squamous Cell Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CryoBalloon Focal Ablation System

CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia

Group Type: EXPERIMENTAL

CryoBalloon Focal Ablation System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

C2 CryoBalloon Focal Ablation System; Coldplay CryoBalloon Focal Ablation System

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pentax Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guiqi Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30922862 (View on PubMed)

Other Identifiers

CP-0013

Identifier Type: -

Identifier Source: org_study_id