C2 Esophageal Squamous Epithelium Dysplasia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Squamous Epithelium Dysplasia
• Intervention / Treatment: Device: C2 CryoBalloonTM Ablation System.

• Study Type: Interventional
• Enrollment (Anticipated): 129
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GUIQI WANG, MD; Phone Number: 0086-10-87788547; Email: wangguiq@126.com
• Study Contact Backup: Name: Yan Ke, MD; Phone Number: 0086-13520186688; Email: keyan@cicams.ac.cn

Study Locations

• China
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Contact: GUIQI WANG, MD; Phone Number: 0086-10-87788547; Email: wangguiq@126.com
    • Contact: YAN KE; Phone Number: 0086-13520186688; Email: keyan@cicams.ac.cn
    • Principal Investigator: Guiqi Wang
  • Changchun, China
    • The First Bethune Hospital of Jilin University
  • Changzhi, China
    • Changzhi People's Hospital
  • Shijiazhuang, China
    • The Second Hospital of Hebei Medical University
    • Contact: ZHIJIE FENG, MD; Phone Number: 0086-15803210958; Email: zhijiefeng2005@163.com
    • Principal Investigator: ZHIJIE FENG, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female of 18 to 80 years old (including 18 and 80 years old).
2. 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.
3. 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.
4. No potential of lymph node metastasis by preoperative comprehensive evaluation.

Exclusion Criteria:

Inclusion criteria:

1. Male or female of 18 to 80 years old (including 18 and 80 years old).
2. 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.
3. 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.
4. No potential of lymph node metastasis by preoperative comprehensive evaluation.
5. The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.

Exclusion criteria:

1. Females who are pregnant, lactating or plan to get pregnant during the study.
2. Known hypersensitivity to iodine.
3. 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.
4. Esophageal stenosis preventing the passage of the endoscope to the treatment area. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4 cm of the treatment area.
5. Having previously received Heller surgery: any previous ablative esophageal surgery (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any previous esophageal surgery except for anti-reflux surgery.
6. Suffering from any cancer in the past 5 years.
7. Severe bleeding potential; patients on anti-coagulative therapy or stopping using anti-coagulative drugs for less than 7 days before enrollment or with impaired coagulation.

9) Patients with unstable vital signs 10) Anti-human immunodeficiency virus (HIV) antibody positive, both syphilis serology Treponema pallidum-specific antibody test and rapid plasma reagin positive.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Intervention; All subjects will receive treatment with the study device.	Device: C2 CryoBalloonTM Ablation System.; Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area	Percentage of complete remission at 12 months	12 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment	Percentage of patients who need only 1 treatment	12 Month
2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area		12 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	Frequency of adverse events and frequency of device related adverse events	12 Months

Collaborators and Investigators

• Sponsor: Pentax Medical

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 31, 2023
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): July 31, 2025

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: CBAS_DIII_19001

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes