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NCT Number: NCT05349240

C2 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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: 12 Month

    Percentage of patients who need only 1 treatment

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

    Time frame: 12 Month

Other outcomes

  1. Safety Endpoints

    Time frame: 12 Months

    Frequency of adverse events and frequency of device related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Guiqi Wang, MD

CONTACT

[email protected]

0086-10-87788547

Yan Ke, MD

CONTACT

[email protected]

0086-13520186688

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.