Actively Recruiting
Study to Evaluate the Safety and Effectiveness of the C2 CryoBalloon Ablation System for Treating Moderate to Severe Esophageal Squamous Epithelium Dysplasia
Led by Pentax Medical · Updated on 2025-01-13
129
Participants Needed
4
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the C2 CryoBalloonTM Ablation System in treating patients with moderate to severe esophageal squamous epithelium dysplasia. This condition involves abnormal, potentially precancerous tissue changes in the esophagus. The study focuses on how well this device can destroy the unhealthy dysplastic tissue under cryogenic conditions. The study involves using the C2 CryoBalloonTM Ablation System to perform cryoablation, which freezes and destroys the abnormal esophageal tissue. Eligible patients have specific lesions in the esophagus identified by endoscopy and confirmed by biopsy. The treatment targets flat unstained lesions no larger than 6 cm and affecting up to half the circumference of the esophagus. The study is prospective, single-arm, and conducted at multiple centers. Participants will undergo assessments including endoscopic examinations with Lugol's staining and biopsy confirmation before treatment. Researchers will measure the percentage of subjects who achieve complete remission of all moderate to severe dysplasia in the treated area at 12 months. Safety and any adverse effects will also be monitored throughout the study. Overall, the study aims to observe treatment outcomes and participant health over the course of at least a year.
CONDITIONS
Official Title
C2 Esophageal Squamous Epithelium Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years (including 18 and 80 years old)
- At least one unstained lesion (USL) in the esophagus found by high resolution upper gastrointestinal endoscopy with Lugol's staining
- Presence of flat (Paris type 0-IIb) USL with total area up to 6 cm longitudinal size and covering no more than half of the esophageal circumference
- Biopsy-confirmed moderate to severe esophageal squamous epithelium dysplasia within 6 months prior to enrollment
- No signs of lymph node metastasis based on preoperative evaluation
- Patients voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Pregnant or lactating females or those planning pregnancy during the study
- Known allergy or hypersensitivity to iodine
- Lesions with obvious ulcers, bleeding-risk varices, active inflammation from reflux, non-flat lesions, or unfavourable unstained lesions outside target areas
- Esophageal stenosis blocking endoscope passage to treatment area or within 4 cm of treatment area
- Prior esophageal ablative surgery (e.g., photodynamic therapy, coagulation, laser) except anti-reflux surgery
- History of any cancer within the past 5 years
- Severe bleeding risk or recent use of anticoagulant therapy within 7 days before enrollment
- Unstable vital signs
- Positive for HIV antibodies or positive syphilis tests
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Trial Site Locations
Total: 4 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
The First Bethune Hospital of Jilin University
Changchun, China
Actively Recruiting
3
Changzhi People's Hospital
Changzhi, China
Actively Recruiting
4
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
Research Team
G
Guiqi Wang, MD
Y
Yan Ke, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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