C2 Esophageal Squamous Epithelium Dysplasia

NCT05349240 | Recruiting FDA Device

• 1 other identifier: CBAS_DIII_19001
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 4

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.

Conditions

Esophageal Squamous Epithelium Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment

  12 Month

• 2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area

  12 Month

Other Outcomes (1)

• Safety Endpoints

  12 Months

Study Arms (1)

Study Intervention

EXPERIMENTAL

All subjects will receive treatment with the study device.

Device: C2 CryoBalloonTM Ablation System.

Interventions

C2 CryoBalloonTM Ablation System. DEVICE

Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.

Study Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Suffering from any cancer in the past 5 years.
• 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.
• \) 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.

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, China

RECRUITING

Changzhi People's Hospital

Changzhi, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, China

RECRUITING

Study Officials

• Guiqi Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guiqi Wang, MD

CONTACT

0086-10-87788547; wangguiq@126.com

Yan Ke, MD

CONTACT

0086-13520186688; keyan@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: April 27, 2022
• Study Start: November 18, 2022
• Primary Completion: March 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)