Cryoablation treatment for esophageal 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 is testing if a new freezing treatment can help people with moderate to severe esophageal dysplasia by removing the abnormal tissue and improving their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pentax Medical (industry)
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT05349240 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the C2 CryoBalloonTM Ablation System for treating dysplastic squamous tissue in patients diagnosed with moderate to severe esophageal squamous epithelium dysplasia. Participants will undergo high-resolution upper gastrointestinal endoscopy to identify lesions, followed by cryoablation to target the affected areas. The study aims to determine how well this intervention works in reducing dysplastic tissue and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with biopsy-confirmed moderate to severe esophageal squamous epithelium dysplasia and specific lesion characteristics.

Not a fit: Patients with lymph node metastasis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a minimally invasive option for patients with esophageal dysplasia, potentially reducing the risk of progression to esophageal cancer.

How similar studies have performed: While this specific approach is novel, similar cryoablation techniques have shown promise in treating dysplastic tissues in other areas, suggesting potential for success.

Eligibility 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.

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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Where this trial is running

Beijing and 3 other locations

• 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 contacts

• Principal investigator: Guiqi Wang, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Guiqi Wang, MD

Conditions: Esophageal Squamous Epithelium Dysplasia