A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia

Pentax Medical4 sites in 1 country129 target enrollmentNovember 18, 2022

ConditionsEsophageal Squamous Epithelium Dysplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Squamous Epithelium Dysplasia
Sponsor: Pentax Medical
Enrollment: 129
Locations: 4
Primary Endpoint: Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.

Registry

clinicaltrials.gov

Start Date

November 18, 2022

End Date

July 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pentax Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female of 18 to 80 years old (including 18 and 80 years old).
•At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.
•Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.
•No potential of lymph node metastasis by preoperative comprehensive evaluation.

Exclusion Criteria

•Inclusion criteria:
•Male or female of 18 to 80 years old (including 18 and 80 years old).
•At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.
•Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.
•No potential of lymph node metastasis by preoperative comprehensive evaluation.
•The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.
•Exclusion criteria:
•Females who are pregnant, lactating or plan to get pregnant during the study.
•Known hypersensitivity to iodine.
•Lesions within the target area such as: obvious ulcer; varices at risk of bleeding; active inflammation due to esophageal reflux into the treatment area; lesions view being not flat, or containing unfavourable unstained lesions (USLs) outside the designated treatment areas.

Outcomes

Primary Outcomes

Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area

Time Frame: 12 Month

Percentage of complete remission at 12 months

Secondary Outcomes

2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area(12 Month)
1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment(12 Month)